RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix
排除标准
- •See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)
- •Additional Appendix A (Hypersomnia) Level Exclusion Criteria:
- •Self-reported sleep duration <6 hours per night
- •Poorly controlled hypertension (systolic blood pressure ≥140 or diastolic blood pressure ≥90 mmHg)
- •Moderate to severe hepatic impairment (ie, Child-Pugh class B or C)*
- •Known estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or chronic dialysis*
- •Recent myocardial infarction (<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator
- •Current use of stimulant or wake-promoting medications, unless a washout is permitted
- •Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period is permitted.
- •characterized by the screening labs: coagulation panel and CMP w/LFTs
- •MODAFINIL EXCLUSION CRITERIA
- •Modafinil can affect drug metabolism given its effect on enzymes such as CYP3A4 and CYP2C
- •To assess for drug interactions, investigators should use the Lexicomp Drug Interactions System that is available at most institutions.
- •o If the search yields "D" - Consider Modifying Therapy or "X" - Avoid Combination, then the ACTION is to exclude the potential participant.
- •An important example of this is steroid hormonal contraceptives.
- •If the search yields "C" - Monitor Therapy, then discuss with site PIs on a case-by-case basis.
- •If the search yields "A" - No Known Interaction or "B" - No Action Needed, then proceed to screen/include the potential participant.
- •Known severe left ventricular hypertrophy, mitral valve prolapse
- •SOLRIAMFETOL EXCLUSION CRITERIA
- •Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
- •Current use of dopaminergic drugs
研究组 & 干预措施
Wake-promoting drug: Modafinil or solriamfetol
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
干预措施: Modafinil (Drug)
Wake-promoting drug: Modafinil or solriamfetol
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
干预措施: Solriamfetol (Drug)
Modafinil-matched placebo or solriamfetol-matched placebo
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
干预措施: Modafinil Placebo (Drug)
Modafinil-matched placebo or solriamfetol-matched placebo
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
干预措施: Solriamfetol Placebo (Drug)
结局指标
主要结局
Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
时间窗: 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.
次要结局
- Change in total score of the PROMIS 8b SD to assess sleep disturbance(Baseline, End of Intervention (Day 77))
- Change in PROMIS 10a Fatigue score(Baseline, End of Intervention (Day 77))
- Change in an objective neurocognitive battery score(Baseline, End of Intervention (Day 77))
- Change in ECog2 measure(Baseline, End of Intervention (Day 77))
- Change in PASC Symptom Questionnaire responses(Baseline, End of Intervention (Day 77))
- Change in total score on the Insomnia Severity Index (ISI)(Baseline, End of Intervention (Day 77))
- Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker(Baseline, End of Intervention (Day 77))
- Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker(Baseline, End of Intervention (Day 77))