Evaluating interventions for sleep disturbances in Long COVID patients
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
This study is testing different ways to help people with Long COVID improve their sleep, including melatonin and special lighting, to see what works best.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06404112 on ClinicalTrials.gov |
What this trial studies
This platform protocol is a multi-center, randomized controlled trial designed to evaluate various interventions aimed at improving sleep disturbances in patients suffering from Long COVID. Participants will undergo baseline assessments and then be randomized into intervention groups based on their specific sleep phenotypes or into a placebo/control group. The interventions include melatonin, tailored lighting, and their respective placebos, allowing for comparative analysis across different treatment approaches. The study aims to address symptoms such as hypersomnia and other complex sleep-related issues associated with post-acute sequelae of SARS-CoV-2 infection (PASC).
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Long COVID who are experiencing sleep disturbances.
Not a fit: Patients with severe visual impairments or those currently on sleep medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide targeted interventions that significantly improve sleep quality and overall well-being for patients with Long COVID.
How similar studies have performed: Other studies have shown promise in addressing sleep disturbances in similar patient populations, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix Exclusion Criteria: • See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix Additional Appendix B (CPSD) Level Inclusion Criteria: The following additional exclusion criteria are to be considered together for determining eligibility. They are separated here by TL and melatonin only for presentation. RESET-PASC presents no additional exclusions. TAILORED LIGHTING EXCLUSION CRITERIA 1. Severe visual impairments affecting sensitivity or ability to respond to light 2. Severe photosensitivity dermatitis 3. Severe progressive retinal disease, eg, macular degeneration 4. Permanently dilated pupil, eg, following certain cataract surgeries 5. Unwilling to remove or not wear blue-light-blocking glasses during TL dosing MELATONIN EXCLUSION CRITERIA 1. Sleep medication, if not willing to washout for 4 weeks.
Where this trial is running
Durham, North Carolina
- All sites listed under NCT06404086 — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Jaelyn R Linski, BA, CCRC
- Email: recoverresearch@duke.edu
- Phone: 919-668-8060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.