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Université DukeRECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
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L'essai clinique NCT06404112 est conçu pour étudier le treatment de COVID long, COVID-19 long, Perturbation du sommeil. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 31 juillet 2024 et vise à recruter 600 participants. Dirigé par l'Université Duke, l'essai devrait être terminé d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 avril 2025.
Résumé succinct
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.
This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).
Description détaillée
Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.
After completing Baseline assessments, participants will be randomized to an intervention group, which is based on their sleep phenotype, or into a placebo/control group.
Titre officiel
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Conditions
COVID longCOVID-19 longPerturbation du sommeilAutres identifiants de l'essai
- Pro00112484_B
- OTA-21-015G (Autre financement) (NIH Grant to RTI; RTI subcontracting with DCRI)
Numéro NCT
Date de début (réel)
2024-07-31
Dernière mise à jour publiée
2025-04-23
Date de fin (estimée)
2025-12-31
Inscription (estimée)
600
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
PASC
Sleep Disturbances
Sleep Disturbances
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifActive TL + Oral Melatonin 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. | Mélatonine Melatonin dosing will be one tablet of 3 mg immediate release daily consumed 2 hours before the participant's desired bedtime, which is defined as the time at which the participant tries to fall asleep. Tailored Lighting (TL) Active TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. |
Comparateur actifActive TL + Placebo Melatonin 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. | Melantonin Placebo Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime. Tailored Lighting (TL) Active TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. |
Comparateur actifPlacebo TL + Oral Melatonin 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. | Mélatonine Melatonin dosing will be one tablet of 3 mg immediate release daily consumed 2 hours before the participant's desired bedtime, which is defined as the time at which the participant tries to fall asleep. Tailored Lighting (TL) Placebo TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. |
Comparateur placeboPlacebo TL + Placebo Melatonin 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. | Melantonin Placebo Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime. Tailored Lighting (TL) Placebo TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in total score of the PROMIS 8b SD to assess sleep disturbance | 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 a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance. | Baseline, End of Intervention (Day 63) |
Change in sleep onset variability, assessed using a wearable device | A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI | Baseline, End of Intervention (Day 63) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in total score of the PROMIS 8a SRI to assess sleep-related impairment | 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 \> 55 1 SD above population mean. | Baseline, End of Intervention (Day 63) |
Change in PROMIS 10a Fatigue score | 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). | Baseline, End of Intervention (Day 63) |
Change in an objective neurocognitive battery score | Baseline, End of Intervention (Day 63) | |
Change in ECog2 measure | 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. | Baseline, End of Intervention (Day 63) |
Change in PASC Symptom Questionnaire responses | 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. | Baseline, End of Intervention (Day 63) |
Change in total score from ISI (Insomnia Severity Index) | 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. | Baseline, End of Intervention (Day 63) |
Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary | Sleep onset time will be assessed by sleep diary | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary | Nocturnal sleep duration will be assessed by sleep diary | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary | 24-hour sleep duration will be assessed by sleep diary | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary | Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker | Nocturnal sleep duration will be assessed by activity tracker | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker | 24-hour sleep duration will be assessed by activity tracker | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker | Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker | Baseline, End of Intervention (Day 63) |
Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker | Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary | Baseline, End of Intervention (Day 63) |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix
• 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
- Severe visual impairments affecting sensitivity or ability to respond to light
- Severe photosensitivity dermatitis
- Severe progressive retinal disease, eg, macular degeneration
- Permanently dilated pupil, eg, following certain cataract surgeries
- 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.
Université Duke544 essais cliniques actifs à explorerContact central de l'essai
Contact: Jaelyn R Linski, BA, CCRC, 919-668-8060, [email protected]
Contact: Barrie L Harper, BSMT (ASCP) PMP, [email protected]
1 Centres de l'essai dans 1 pays
North Carolina
All sites listed under NCT06404086, Durham, North Carolina, 27710, United States
En recrutement