Trial · NCT06404099
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
NCT06404099, Phase 2, Completed, Duke University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia). Trials, record NCT06404099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06404099
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
- NCT number
- NCT06404099
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 361 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Long COVID, Long COVID-19, Hypersomnia
- Interventions
- Modafinil, Modafinil Placebo, Solriamfetol, Solriamfetol Placebo
- First posted
- 2024-05-08
- Last updated
- 2026-06-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in total score of the PROMIS 8a SRI to assess sleep-related impairment | Baseline, End of Intervention (Day 77) | The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate greater sleep-related impairment. |
| Secondary | Change in total score of the PROMIS 8b SD to assess sleep disturbance | Baseline, End of Intervention (Day 77) | The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with \> 55 1 SD above population mean. |
| Secondary | Change in PROMIS 10a Fatigue score | Baseline, End of Intervention (Day 77) | The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much). |
| Secondary | Change in an objective neurocognitive battery score | Baseline, End of Intervention (Day 77) | |
| Secondary | Change in ECog2 measure | Baseline, End of Intervention (Day 77) | Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete. |
| Secondary | Change in PASC Symptom Questionnaire responses | Baseline, End of Intervention (Day 77) | Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC. |
| Secondary | Change in total score on the Insomnia Severity Index (ISI) | Baseline, End of Intervention (Day 77) | The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks. |
| Secondary | Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary | Baseline, End of Intervention (Day 77) | Sleep onset time will be assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary | Baseline, End of Intervention (Day 77) | Nocturnal sleep duration will be assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary | Baseline, End of Intervention (Day 77) | 24-hour sleep duration will be assessed by sleep diary |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06404099
GET https://conductscience.org/api/trials/v1/NCT06404099/registered