Tailored Lighting and Melatonin for Sleep Disorders in Long COVID

Phase 2

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of intervention (day 63)

Summary

This trial is looking at different interventions to help improve sleep problems in patients with Post-Acute Sequelae of SARS-CoV-2 (PASC). The trial uses a flexible protocol that

Who is the study for?

This trial is for individuals experiencing sleep disorders after COVID-19, often referred to as Long COVID. Participants should meet the general criteria listed in a related document (NCTXXXXXXXXX). Specific details about who can join are not provided here.

What is being tested?

The study tests if tailored lighting or melatonin can improve sleep issues in post-COVID patients. It's a multi-center trial where participants are randomly assigned to receive either real treatments or placebos for comparison.

What are the potential side effects?

Potential side effects may include typical reactions to melatonin such as drowsiness, headache, and dizziness. Tailored lighting is generally safe but could cause eye strain or disrupt normal sleep patterns if misused.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of intervention (day 63)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of intervention (day 63)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of intervention (day 63) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sleep onset variability, assessed using a wearable device

Change in total score of the PROMIS 8b SD to assess sleep disturbance

Secondary study objectives

Change in ECog2 measure

Change in PASC Symptom Questionnaire responses

Change in PROMIS 10a Fatigue score

+10 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Active TL + Oral MelatoninActive Control2 Interventions

The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.

Group II: Active TL + Placebo MelatoninActive Control2 Interventions

Group III: Placebo TL + Oral MelatoninActive Control2 Interventions

Group IV: Placebo TL + Placebo MelatoninPlacebo Group2 Interventions

0 / 1Eligibility criteria met