RECOVER-SLEEP enrollment process prioritized overall health of potential participants

The RECOVER-SLEEP study team recently completed enrollment for 2 RECOVER clinical trials focused on sleep disturbances. These trials, RECOVER-SLEEP Hypersomnia (Modafinil/Solriamfetol) and RECOVER-SLEEP Complex Sleep Disturbances (Melatonin + Light Therapy), will include a total of 830 participants at 47 sites across the United States. 

RECOVER-SLEEP trials started recruiting participants in June 2024 and asked potential participants questions about their sleep symptoms, how they were feeling, and completed other tests to see if they met the criteria for the studies. This process is often referred to as “screening.” In total, more than 1,200 potential participants were screened for the RECOVER-SLEEP trials.

Here’s what each trial is testing: 

• RECOVER-SLEEP Hypersomnia (Modafinil/Solriamfetol) is testing modafinil, a drug that has been used to help people stay awake during the day, for 10 weeks. Participants who can’t take modafinil because of interactions with their other medications might have been asked to take solriamfetol (a drug like the study drug) or a placebo, a pill that looks like the study drug but has no active ingredients and should have no effect. 
• RECOVER-SLEEP Complex Sleep Disturbances (Melatonin + Light Therapy) is testing combinations of melatonin (a natural hormone in the brain that helps regulate the timing of sleep) and light to test the impact on people who have poor sleep quality or problems falling asleep or staying asleep due to Long COVID. 

Researchers added additional screening test to help overall health

Sleep apnea is a common condition that causes your breathing to stop and restart many times while you sleep. This can prevent your body from getting enough oxygen and can be an especially difficult problem for people living with Long COVID. Although the condition is common, it requires a test to diagnose and often requires treatment to improve overall health. 

“Sleep apnea causes sleepiness and sleep disruption,” said Susan Redline, MD, MPH, co-chair of the RECOVER-SLEEP trials and a pulmonologist and sleep medicine specialist at Harvard Medical School. “Sleep apnea also may impact many of the body’s repair functions, making it harder to recover from Long COVID.”

The RECOVER-SLEEP researchers decided that they did not want to exclude people with untreated sleep apnea from the chance to take part in the studies. But they did need to know if people had the condition before they asked them to try other potential treatments for their sleep symptoms. Researchers also consulted with RECOVER-SLEEP Representatives, who are people living with or caring for people living with Long COVID, about testing for sleep apnea as part of the screening process.

“When we shared some of these ideas with the Representatives, they were very enthusiastic,” said Dr. Redline. “They talked about how they or their friends or their spouses had sleep apnea. They knew that there was a connection, and they really endorsed having sleep apnea screening as a benefit for people being screened to take part in the study.”

Sleep apnea testing and treatments provided to all who needed them

About 450 potential participants received the sleep apnea screening. The study teams asked questions about sleep habits, previous diagnoses, and other symptoms to find out if more testing was needed. If participants were not likely to have the condition, they were not given the sleep apnea test.

People who needed the sleep apnea test were given a Home Sleep Apnea Test, which allowed them to avoid a trip to a sleep clinic. Researchers chose a home test because travel can be a barrier for people living with Long COVID.

“We know sleep apnea treatments work, and people with sleep apnea should get treated for the condition,” said Dr. Redline. “We wanted to make sure that anybody with clinically significant sleep apnea was offered therapy and had an opportunity to receive sleep apnea treatment.”

If a participant did have sleep apnea and needed treatment, the study team either referred them to their physician for treatment or offered patients a common treatment called a Continuous Positive Airway Pressure (CPAP) machine, which helps keep airways open during sleep. This approach allowed potential participants to receive sleep apnea treatment and then return to the study site to find out if they qualified for one of the trials after the condition was treated.

Once potential participants were ready to join a study, they completed the screening process to see if they qualified for one of the 2 RECOVER-SLEEP trials. The final participants were enrolled in December and will be in the study for up to 4 months. Investigators plan to share results in late 2026. 

For full details on the RECOVER-SLEEP studies, please visit the ClinicalTrials.gov study listings for RECOVER-SLEEP Hypersomnia (Modafinil/Solriamfetol) and RECOVER-SLEEP Complex Sleep Disturbances (Melatonin + Light Therapy), as well as the RECOVER-SLEEP platform protocol.