Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404099
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-06
Brief Title:
RECOVER-SLEEP Platform Protocol Appendix_A Hypersomnia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
RECOVER-SLEEP A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 placebocontrol group
After completing Baseline assessments participants will be randomized to an intervention group which is based on their sleep phenotype or into a placebocontrol group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTA-21-015G | OTHER_GRANT | NIH Grant to RTI RTI subcontracting with DCRI | None |