NIH Announces New Trials to Study Sleep Disruption and Post-Exertional Malaise in Long COVID Patients

The National Institutes of Health (NIH) announced that they will “launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM).”

The studies will be part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, and will join six other RECOVER studies “currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.”

One of the new groups of clinical trials, termed “RECOVER-SLEEP,” will test two drugs approved by the FDA “to treat people who have problems staying awake during the day, known as hypersomnia. These medications are well-known but have not been studied widely in people with long COVID.” It will also “test potential treatments for complex sleep disturbances due to long COVID, including melatonin…and light therapy.”

Meanwhile, “RECOVER-ENERGIZE” clinical trials will “test a program that combines exercise training, strength and flexibility training, education, and social support, collectively known as personalized cardiopulmonary rehabilitation. The program is designed to help people who experience exercise intolerance with symptoms such as shortness of breath and fatigue during exercise after having COVID-19.” It will also test “a program known as structured pacing, which is designed to help participants with PEM identify, control, and minimize symptoms that developed after having COVID-19 by regulating or pacing their daily activities.”