Sleep Disturbance Severity and Correlates in Post-acute Sequelae of COVID-19

 

Cinthya Pena-Orbea MD, 

Brittany Lapin PhD, 

Yadi Li MEd, 

Kristin Englund MD, 

Catherine Heinzinger MD, 

Nancy Foldvary-Schaefer DO, MS & 

Reena Mehra MD, MS 

INTRODUCTION

Post-acute COVID-19 syndrome (PASC) is a global public health crisis in which patients experience lingering and debilitating symptoms beyond 4 weeks after the acute onset of SARS-CoV-2 infection.1 Sleep disturbance has a reported prevalence of 34–50% in PASC,2,3 but only a few studies have identified associated risk factors, and these have primarily described sleep quality and not symptom severity.3,4 Likewise, studies to date have not investigated the interaction of mood disorders and fatigue with sleep disturbance severity or the association of objective sleep study indices in PASC.

METHODS

Patients with PASC1 were evaluated at the Cleveland Clinic ReCOver Clinic between February 2021 and April 2022. Patients ≥ 18 years old who completed Patient-Reported Outcomes Measurement Information System (PROMIS)5 Sleep Disturbance within 90 days or during their initial ReCOver clinic visit were prospectively examined. Demographics and clinical characteristics were extracted from the COVID-19 Cleveland Clinic Registry. In a subset with pre-infection sleep studies available, Apnea Hypopnea Index (AHI) and hypoxia measures (mean oxygen saturation [SaO2%] and percentage of time spent < 90% oxygen saturation [T90]) were extracted. Patient-reported outcomes collected during the initial ReCOver clinic visit from the Electronic Medical Record included PROMIS Sleep Disturbance, Fatigue, and Global Health (PROMIS-GH) v1.2, Generalized Anxiety Disorder (GAD)-2, Patient Health Questionnaire (PHQ)-2, and the Quality of Life in Neurological Disorders (Neuro-QoL) v1.0 Cognitive Function. PROMIS scores were standardized on a T-scale with mean 50 (SD 10)6, with established cut-points at > 55, > 60, and > 70 for mild, moderate, and severe sleep disturbance respectively.6 Multivariable models were constructed to identify independent predictors of moderate to severe sleep disturbances based on clinically relevant variables determined a priori. Interactions between mood disorders and fatigue using PROMIS Fatigue, PHQ-2, and GAD-2 scores were tested.

RESULTS

A total of 962 of 1660 patients completed the PROMIS Sleep Disturbance; 565 (58.7%) had normal to mild sleep disturbance and 397 (41.3%) had moderate to severe sleep disturbance with characteristics shown in Table 1. After adjustment (Table 2), Black race (OR = 1.84, 95%CI: 1.10–3.08, p = 0.020), hospitalization for COVID-19 (OR = 1.59, 95%CI: 1.10–2.32, p < 0.015), greater anxiety severity (OR = 1.31, 95%CI: 1.18–1.45, p < 0.001), and moderate to severe fatigue (OR = 2.03, 95%CI: 1.33–3.11, p = 0.001) were significantly associated with moderate to severe sleep disturbance. Statistical interactions of anxiety severity and moderate to severe fatigue were not significant (p = 0.84).

Forty-eight patients had pre-COVID-19 sleep testing conducted 2.6 ± 2.1 years prior to the initial ReCOver Clinic appointment. AHI, the primary measure of obstructive sleep apnea (OSA) severity, was 15.4 ± 18.9 with mean SaO2 of 92 ± 2.3% and a median T90% of 12.1 [2.8,73.3] (Table 1). OSA (AHI:18.7 ± 24.4 vs 12.4 ± 11.8, p = 0.27) and hypoxia measures (mean SaO2%: 91.5 ± 2.8 vs 92.5 ± 1.6, p = 0.14; median T90% 16.5 [3.5, 83.2]vs 9.3 [1.8, 44.3], p = 0.32) were not statistically different between normal to mild and moderate to severe sleep disturbance.

DISCUSSION

Novel findings include a high prevalence of 41.3% of moderate to severe sleep disturbance in PASC associated with Black race, hospitalization for COVID-19, anxiety severity, and moderate to severe fatigue. There was no significant interaction between anxiety severity and moderate to severe fatigue; further studies are needed to investigate the interplay between mental and sleep disturbances in PASC physiologic pathways. Likewise, there was no association between objective sleep study measures of antecedent sleep apnea and hypoxia with sleep disturbance. This may be explained by the small sample size, testing indication biases, or limitations of sleep study type (i.e., home sleep apnea test), precluding assessment of objective sleep quality or quantity measures. With 58% of PASC patients completing PROMIS Sleep Disturbance, our study may suffer from selection bias. However, we observed that among patients of Black race who did not complete PROMIS Sleep Disturbance, 60% completed mood and fatigue questionnaires. As such, it is possible that the magnitude of association between Black race and moderate to severe sleep disturbances is even stronger. Study findings emphasize the importance of identification of sleep disturbance in PASC considering its impact on patients’ quality of life, daytime functioning, and medical health status. Results inform risk stratification and highlight the need to elucidate contributions of structural racism and socioeconomic inequities to PASC-related sleep disturbances with the goal of developing interventions to reduce PASC disparities.

https://link.springer.com/article/10.1007/s11606-023-08187-3

Ursodeoxycholic acid tied to reduction in SARS-CoV-2 infection and reduced severity

 Binu V. John, Dustin Bastaich, Gwilym Webb, Teresa Brevini, Andrew Moon, Raphaella D. Ferreira, Allison M. Chin, David E. Kaplan, Tamar H. Taddei, Marina Serper, Nadim Mahmud … See all authors



https://doi.org/10.1111/joim.13630

Abstract

Background and aims

Studies have demonstrated that reducing farnesoid X receptor activity with ursodeoxycholic acid (UDCA) downregulates angiotensin-converting enzyme in human lung, intestinal and cholangiocytes organoids in vitro, in human lungs and livers perfused ex situ, reducing internalization of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into the host cell. This offers a potential novel target against coronavirus disease 2019 (COVID-19). The objective of our study was to compare the association between UDCA exposure and SARS-CoV-2 infection, as well as varying severities of COVID-19, in a large national cohort of participants with cirrhosis.

Methods

In this retrospective cohort study among participants with cirrhosis in the Veterans Outcomes and Costs Associated with Liver cohort, we compared participants with exposure to UDCA, with a propensity score (PS) matched group of participants without UDCA exposure, matched for clinical characteristics, and vaccination status. The outcomes included SARS-CoV-2 infection, symptomatic, at least moderate, severe, or critical COVID-19, and COVID-19-related death.

Results

We compared 1607 participants with cirrhosis who were on UDCA, with 1607 PS-matched controls. On multivariable logistic regression, UDCA exposure was associated with reduced odds of developing SARS-CoV-2 infection (adjusted odds ratio [aOR] 0.54, 95% confidence interval [CI] 0.41–0.71, p < 0.0001). Among patients who developed COVID-19, UDCA use was associated with reduced disease severity, including symptomatic COVID-19 (aOR 0.54, 95% CI 0.39–0.73, p < 0.0001), at least moderate COVID-19 (aOR 0.51, 95% CI 0.32–0.81, p = 0.005), and severe or critical COVID-19 (aOR 0.48, 95% CI 0.25–0.94, p = 0.03).

Conclusions

In participants with cirrhosis, UDCA exposure was associated with both a decrease in SARS-CoV-2 infection, and reduction in symptomatic, at least moderate, and severe/critical COVID-19.

https://onlinelibrary.wiley.com/doi/10.1111/joim.13630

Tongue Nerve Stimulator Does Good for Sleep Apnea Patients

 Targeted hypoglossal nerve stimulation (THN) showed safety and efficacy for patients with moderate-to-severe obstructive sleep apnea (OSA), the randomized THN3 trial found.

Four months after receiving a THN device, patients who had had their devices activated at month 1 were more likely to meet criteria for treatment response in terms of reduced apnea-hypopnea index (AHI; 52.3% vs 19.6%) and improved oxygen desaturation index (ODI; 62.5% vs 41.3%) compared with controls who had not had their devices turned on yet.

"During the 4-month randomization period, THN therapy significantly improved measures of sleep-disordered breathing and patient-reported outcomes, including daytime somnolence and quality of life in treated vs control participants," reported Alan Schwartz, MD, of the Hospital of the University of Pennsylvania in Philadelphia, and coauthors in JAMA Otolaryngology-Head & Neck Surgery.

opens in a new tab or window

After the 4-month mark, the controls had THN implants activated as well and joined the early-activation arm. In this combined treatment group, AHI and ODI response rates were 42.5% and 60.4%, respectively, at month 12/15, indicating some reduction in response -- and resulting in the long-term AHI response rate not meeting its prespecified efficacy endpoint.

Nevertheless, patients reported improvements in their Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and European Quality of Life 5-Dimension visual analog scale scores.

"Although AHI response rates appeared to decline during the period of longitudinal follow up, clinically important reductions in OSA burden were maintained, with comparable decreases in AHI and ODI after nearly a year of therapy in the entire group," the authors wrote. "Patient-reported outcomes further suggest that reductions in OSA severity, even without complete remission, can achieve clinically meaningful improvements in sleep quality and daytime function."

The trial tested the aura6000 THN therapy system

opens in a new tab or window from ImThera Medical, which consists of an implanted pulse simulation device and a lead that transports the generated pulses to the hypoglossal nerve to activate their lingual muscles and to keep airways clear. Patients are given a remote that allows them to control the process of their nightly THN therapy.

As for safety, Schwartz's group reported two severe adverse events related to treatment: one case of neck pain as the result of lead tension and one instance of lead dislodgement. Furthermore, 6.5% of patients received replacements, explants, or revisions, and 72.5% experienced some form of adverse event ranging from perioperative wound events to stimulation discomfort.

These results come more than a decade after the year-long pilot studyopens in a new tab or window of the aura6000 system that supported THN as a viable treatment option for OSA, and nearly a decade after FDA approval of the Inspire upper airway stimulation deviceopens in a new tab or window, another implanted nerve stimulation therapy for severe OSA, which has since seen expandedopens in a new tab or window indicationsopens in a new tab or window from the original approval in adults.

While the similarities between the two systems are clear, THN may be more applicable to patients since the aura6000 THN trial had more broad parameters for inclusion than the long-standing STAR trial

opens in a new tab or window that had tested the Inspire.

If THN makes it to market, it is still unlikely that it will replace the Inspire, which "has had 9 years to become the mainstay of hypoglossal nerve stimulation, with refinement in patient care resources, support for surgeons, and demonstration of long-term improvements in OSA-related outcomes," according to Ryan Jackson, MD, of the Washington University School of Medicine in St. Louis, Missouri, and Sebastian Jara, MD, MPH, of the University of Washington School of Medicine in Seattle.

"Nonetheless, if THN achieves FDA approval, it will provide a compelling additional surgical option for hypoglossal nerve stimulation with several advantages, including potentially elimination of the need for preoperative screening with [drug-induced sleep endoscopy] for insurance authorization. This will ease patient access to therapy, promote adoption of THN by surgeons, and thus provide welcome competition to spur further innovation in hypoglossal nerve stimulation," the duo noted in an accompanying editorialopens in a new tab or window.

THN3 was a trial testing proximal THN stimulation in positive airway pressure-intolerant patients with moderate to severe OSA. Data were collected from May 2015 to June 2018.

A total of 138 participants were included in the cohort (13.8% women, average age 56 years old, BMI 30). Median AHI was 36.5 events per hour and median ODI 35.1 per hour, indicating severe OSA at baseline.

Baseline characteristics were comparable between treatment and control arms except for more women and a slightly higher average AHI and greater time spent during sleep with oxygen saturation less than 90% in the treatment group.

The THN implant procedure took a median 77.5 minutes and 72% of patients were discharged on the same day.

Prespecified thresholds for THN response were a 50% or greater reduction in AHI to ≤20 per hour and an ODI decrease of 25% or greater.

Investigators reported that the treatment was not only successful, but fairly popular among participants. Over 80% said that they found using THN easy, that they were "satisfied or very satisfied with their outcome," that they would be willing to go through treatment again, and that they would recommend this form of treatment.

Among the limitations of the study, however, was that patients were not blinded to the treatment they received and that results may not be generalizable outside the studied patient population.

Disclosures

Schwartz reported relationships with ImThera, LivaNova, the AE Mann Foundation, Deerfield Catalyst, Invicta Medical, Nyxoah, Respicardia/Zoll, Apnimed, Itamar/Zoll, Periodic Breathing, Respimetrix, and Sunrise.

Jackson reported consulting fees from Intuitive.

Jara had no disclosures to report.

Primary Source

JAMA Otolaryngology-Head & Neck Surgery

Source Reference: opens in a new tab or windowSchwartz AR, et al "Targeted hypoglossal nerve stimulation for patients with obstructive sleep apnea: a randomized clinical trial" JAMA Otolaryngol Head Neck Surg 2023; DOI: 10.1001/jamaoto.2023.0161.

Secondary Source

JAMA Otolaryngology-Head & Neck Surgery

Source Reference: opens in a new tab or windowJara SM, Jackson RS "Targeted hypoglossal nerve stimulation -- an inspiring alternative for obstructive sleep apnea" JAMA Otolaryngol Head Neck Surg 2023; DOI: 10.1001/jamaoto.2023.0231.

https://www.medpagetoday.com/pulmonology/sleepdisorders/103900

Leading Causes of Death Hit Childhood Cancer Survivors Earlier

Survivors of childhood cancer had a fourfold higher risk of mortality decades after their diagnosis, typically from the same leading causes of death afflicting the general U.S. population, a report from the Childhood Cancer Survivor Study (CCSS) showed.

The 40-year all-cause mortality rate was 23.3% among the more than 34,000 pediatric cancer patients who had survived at least 5 years from the time of their diagnosis, compared with the under 5% rate expected in the general population, reported Stephanie Dixon, MD, of St. Jude Children's Research Hospital in Memphis, Tennessee, and colleagues in The Lancetopens in a new tab or window.

By 40 years from the time of diagnosis, survivors experienced 138 excess deaths per 10,000 person-years, of which 131 were attributable to health-related causes, including those due to the top three causes of mortality:

• Cancer: 54 excess deaths per 10,000 person-years
• Heart disease: 27 excess deaths per 10,000 person-years
• Cerebrovascular disease: 10 excess deaths per 10,000 person-years

Although 5-year survival after childhood cancer has improved dramatically over the past 50 years, "it is well known that cancer and cancer treatment contribute to an increased risk of late morbidity and mortality among long-term survivors," Dixon and her colleagues wrote. They observed that while this study showed that many of the causes of death experienced in late survivors are the same as the major causes of death in the general U.S. population, "survivors are dying at a younger and higher rate."

However, the researchers found that when survivors were stratified by lifestyle score and cardiovascular risk factors, the excess risk of health-related death was lowest in the survivors with a healthy lifestyle.

In multivariable models adjusted for therapy exposures and sociodemographic factors, a healthy versus unhealthy lifestyle was associated with a 20% decreased risk of health-related mortality independent of traditional cardiovascular risk factors. Meanwhile, a moderately healthy lifestyle was associated with a 10% decreased risk.

The absence of reported hypertension or diabetes were each associated with a 30% decreased risk of health-related mortality overall, including a 30% to 50% decreased risk of cardiac mortality, independent of lifestyle and other cardiovascular risk factors.

"Fortunately, the potential exists to mitigate this risk by healthy lifestyle and absence of traditional cardiovascular risk factors," wrote Dixon and colleagues. "Continued reductions in intensity of primary cancer therapy and future research targeting interventions for modifiable lifestyle and cardiovascular risk factors in survivors could offer an opportunity to reduce morbidity and extend the lifespan for survivors."

In a commentary accompanying the studyopens in a new tab or window, Emily Tonorezos, MD, MPH, of the National Cancer Institute in Rockville, Maryland, and Valérie Marcil, RD, PhD, of the University of Montreal, said the findings "provide a roadmap for reducing late mortality among childhood cancer survivors and have implications for providers, researchers, and policymakers."

"Although advances in treatment continue to improve prognosis for children diagnosed with cancer, health-related late mortality must be reduced to have a lasting effect," they continued. "Clearly, strategies to reduce smoking and heavy alcohol use, and improve body weight and physical activity among childhood cancer survivors are urgently needed."

The CCSS cohort in the study included 34,230 pediatric cancer patients who were 5-year survivors. They were diagnosed between 1970 and 1999 from 31 participating centers in the U.S. and Canada. The study had a median follow-up from diagnosis of 29 years.

Within the study population, there were 5,916 deaths, with 34.0% attributable to recurrence or progression of the primary cancer and 51.2% attributable to health-related causes other than recurrence.

Compared with the general population, survivors were at elevated risk of death (standardized mortality ratio 5.6, 95% CI 5.4-5.7) with an 18-fold increased risk at 5 to 9 years from diagnosis that eventually plateaued at about a fourfold increased risk at 20 years after diagnosis.

Absolute excess risk differed by diagnosis. For instance, survivors of acute lymphoblastic leukemia had fewer than 100 excess deaths per 10,000 person-years at all follow-up timepoints, while Hodgkin lymphoma survivors saw their risk of late mortality increase (from 100 excess deaths per 10,000 person-years 25 years from diagnosis, to nearly 400 per 10,000 person-years 40 years or more from diagnosis).

Importantly, specific treatment exposures were independently associated with dose-dependent mortality, and increased risk for all-cause and health-related mortality. Dixon and her colleagues noted that 30 years after diagnosis, alkylator chemotherapy and radiation exposure to the brain or chest were significantly associated with increased all-cause and health-related mortality, and anthracycline chemotherapy with cardiac-specific mortality.

"[C]hanges in primary cancer therapy that reduce exposure to treatments known to cause late effects decades after treatment should remain a priority," they observed.

Disclosures

The study was funded by the National Cancer Institute and the American Lebanese Syrian Associated Charities.

The study authors and editorialists had no disclosures.

Primary Source

The Lancet

Source Reference: opens in a new tab or windowDixon S, et al "Specific causes of excess late mortality and association with modifiable risk factors among survivors of childhood cancer: a report from the Childhood Cancer Survivor Study cohort" Lancet 2023; DOI: 10.1016/S0140-6736(22)02471-0.

Secondary Source

The Lancet

Source Reference: opens in a new tab or windowTonorezos E, Marcil V "Childhood cancer survivors: healthy behaviours and late mortality" Lancet 2023; DOI: 10.1016/S0140-6736(22)02632-0

https://www.medpagetoday.com/hematologyoncology/othercancers/103902

Justice Thomas Crushes Left's 'Billionaire-Funded-Trips' Impeachment Dreams

 Ever since the rapist-accepting nazification of The Supreme Court during President Trump's term in office, the left has been desperate for ways to counter the trans-friendly conservative majority.

The latest cunning plan was to demand Justice Clarence Thomas be immediately impeached for - what can only be summarized as - having rich friends.

In case you missed it, the left was gleeful and cries of 'we got em this time' rang out on Twitter after:

ProPublica revealed in so-called bombshell reporting that right-wing Supreme Court Justice Clarence Thomas has been taking luxury trips funded by a billionaire Republican megadonor for more than 20 years without formally disclosing them - a likely violation of federal law.

The investigative outlet reported Thursday that "for more than two decades, Thomas has accepted luxury trips virtually every year" from Dallas-based real estate magnate Harlan Crow.

"These trips appeared nowhere on Thomas' financial disclosures," the outlet noted.

"His failure to report the flights appears to violate a law passed after Watergate that requires justices, judges, members of Congress, and federal officials to disclose most gifts, two ethics law experts said. He also should have disclosed his trips on the yacht, these experts said."

Thomas’s critics in Congress promptly seized on the report last week of the vacations, suggesting it raised the appearance of impropriety.

As The Epoch Times' Matthew Vadum reported, Rep. Alexandria Ocasio-Cortez (D-N.Y.) demanded that the justice be impeached, saying his actions evidenced an “almost cartoonish” level of corruption.

Sen. Sheldon Whitehouse (D-R.I.), who chairs the Senate Judiciary Committee’s panel on federal courts, called for an independent investigation of the justice, who has long been a target of the left.

Whitehouse and other critics also say that justices whose spouses are involved in political activism, like Thomas, whose wife, Ginni Thomas, a supporter of former President Donald Trump, is active in conservative politics, should have to recuse themselves from involvement in cases related to that activism. Despite pressure, the justice declined to recuse himself from the various challenges to the disputed 2020 presidential election that made it to the Supreme Court.

Billionaire businessman and Republican Party donor Harlan Crow, who made the gifts to Thomas, has reportedly not had any business before the Supreme Court, so any allegation of a conflict of interest rests on weak grounds.

Crow reportedly said the trips with Thomas and his wife were “no different from the hospitality that we have extended to many other dear friends.”

“Justice Thomas and Ginni never asked for any of this hospitality,” he said.

Thomas responded to the circus in a statement released by the Supreme Court’s public information office on April 7 that Harlan Crow, and his wife, Kathy Crow, have been friends with Thomas and his wife “for over twenty-five years.”

“As friends do, we have joined them on a number of family trips during the more than quarter century we have known them,” the justice said.

“Early in my tenure at the Court, I sought guidance from my colleagues and others in the judiciary, and was advised that this sort of personal hospitality from close personal friends, who did not have business before the Court, was not reportable."

“I have endeavored to follow that counsel throughout my tenure, and have always sought to comply with the disclosure guidelines. "

Furthermore, as is usually the case, the leftist media (and the twitterati) were too fast to jump on this as Adam Mortara noted on Twitter, there's no there, there...

Specifically:

But, but, but, the left exclaimed... the rules have changed...

And sure enough, Justice Thomas knew that too, and explained...

"These guidelines are now being changed, as the committee of the Judicial Conference responsible for financial disclosure for the entire federal judiciary just this past month announced new guidance."

“And, it is, of course, my intent to follow this guidance in the future,” Thomas said.

Additionally, attorney J. Christian Adams, president of the Public Interest Legal Foundation (PILF), said he doubts the new ethics regulations apply to the Supreme Court.

“I think there is a fair chance they are unconstitutional,” Adams said.

“The Constitution does not give Congress the power to regulate the Supreme Court’s behavior,” he said.

So having cleared all that up and silenced the impeachment-demanders, we have one simple question still: Why now? The State Security Apparatus would have known about this for years. Why is it coming out now?

https://www.zerohedge.com/political/justice-thomas-crushes-lefts-billionaire-funded-trips-impeachment-dreams

China holds the key to understanding COVID-19 origins: WHO chief

 The World Health Organization chief pressed China on Thursday to share its information about the origins of COVID-19, saying that until that happened all hypotheses remained on the table, more than three years after the virus first emerged.

"Without full access to the information that China has, you cannot say this or that," said Director-General Tedros Adhanom Ghebreyesus in response to a question about the origin of the virus.

"All hypotheses are on the table. That's WHO's position and that's why we have been asking China to be cooperative on this."

"If they would do that then we will know what happened or how it started," he said.

The virus was first identified in the Chinese city of Wuhan in December 2019, with many suspecting it spread in a live animal market before fanning out around the world and killing nearly 7 million people.

Data from the early days of the COVID pandemic was briefly uploaded by Chinese scientists to an international database last month.

It included genetic sequences found in more than 1,000 environmental and animal samples taken in January 2020 at the Huanan seafood market in Wuhan, the location of the first known COVID outbreak.

The data showed that DNA from multiple animal species - including raccoon dogs - was present in environmental samples that tested positive for SARS-CoV-2, the virus that causes COVID, suggesting that they were "the most likely conduits" of the disease, according to a team of international researchers.

However, in a non-peer reviewed study published by the Nature journal this week, scientists with China's Center for Disease Control and Prevention have disputed the international team's findings.

They said the samples provided no proof the animals were actually infected. They were also taken a month after human-to-human transmission first occurred at the market, so even if they were COVID-positive, the animals could have caught the virus from humans.

https://news.yahoo.com/china-holds-key-understanding-covid-154111705.html

Former NCAA Swimmer Riley Gaines Assaulted By Trans Activists At San Fran University Speech

 Outspoken women's rights activist and former NCAA swimmer Riley Gaines - who first made headlines for speaking out for being snubbed of a trophy in favor of trans swimmer Lia Thomas - was assaulted by a pro-trans crowd at a speech at San Francisco State University Thursday night.

She was "physically assaulted" following a speech she made at a Turning Point USA event, Fox News reported. 

Her husband, Louis Barker, said she had to be barricaded in a room for nearly three hours to protect herself after. 

He said: "She told me she was hit multiple times by a guy in a dress. I was shaking. It made me that mad. It makes me sick to feel so helpless about it. She was under police protection and was still hit by a man wearing a dress."

She wrote on Twitter after the incident: "The prisoners are running the asylum at SFSU...I was ambushed and physically hit twice by a man. This is proof that women need sex-protected spaces. Still only further assures me I'm doing something right. When they want you silent, speak louder."

She also posted video of the chaos that ensued after the incident: 

Eli Bremer, Gaines' agent, told Fox News: "Tonight, Riley Gaines spoke at San Francisco State University to share her personal story of competing against a biological male athlete, Lia Thomas, at the Women’s NCAA Swimming Championships last year."

Bremer continued: "In the past year, her goal in speaking at universities has been to educate her peers about her experience and what the impact of the growing number of biological males in women’s sports will do to the integrity of Title IX. She has been questioned in civil and somewhat uncivil manners about her views many times, and she thoroughly encourages diverse viewpoints and debate on this issue."

"Instead of a thoughtful discussion tonight at SFSU, Riley was violently accosted, shouted at, physically assaulted, and barricaded in a room by protestors. It is stunning that in America in 2023, it is acceptable for biological male students to violently assault a woman for standing up for women’s rights. This will not stop Riley from boldly educating people of the dangers of biological males in women’s sports. She will continue to speak the truth against the radical left that no longer understands the difference between men and women."

This was the initial speech that catapulted Gaines to prominence:

https://www.zerohedge.com/markets/former-ncaa-swimmer-riley-gaines-assaulted-trans-activists-after-speech-saving-womens