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NCT06404099 · ClinicalTrials.gov registry record · Phase 2

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

A Phase 2 study of Long COVID and Long COVID-19, sponsored by Duke University.

Active
Registry status
Phase 2
Development phase
361
Enrollment target
1
Study location

NCT06404099 is a Phase 2 study of Long COVID and Long COVID-19 that is active but no longer recruiting, run by Duke University. The registered enrollment target is 361 participants, below the 2,181-participant average among 50 other Long COVID trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06404099, a Phase 2 study of Long COVID and Long COVID-19, is active but no longer recruiting, sponsored by Duke University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
361 participants
Enrollment target
1
Study location

Study 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).

Conditions Studied

Long COVID Long COVID-19 Hypersomnia

Interventions

  • DRUG Modafinil
  • DRUG Solriamfetol
  • DRUG Modafinil Placebo
  • DRUG Solriamfetol Placebo

Study Locations (1)

North Carolina

  • All sites listed under NCT06404086 - Durham

Trial Details

FieldValue
Enrollment Target 361 participants
Start Date 2024-08-12
Est. Completion 2026-04-15
Phase Phase 2

Sponsor

Duke University

1,725 total trials

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What the Registry Record Tells You About NCT06404099

The ClinicalTrials.gov registry entry for NCT06404099 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 361 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,181-participant average among 50 other Long COVID trials with a reported enrollment target (83% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Long COVID appearing as the primary indexed condition, and to 4 interventions - of which Modafinil is the first listed.

NCT06404099 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT06404099 about?

NCT06404099 is a clinical study titled "RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)". 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. ...

What is the current status of trial NCT06404099?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 361 participants. The study started on 2024-08-12. Estimated completion is 2026-04-15.

What conditions does trial NCT06404099 study?

This clinical trial studies the following conditions: Long COVID, Long COVID-19, Hypersomnia.

What interventions are being tested in trial NCT06404099?

The interventions under investigation include: Modafinil (DRUG), Solriamfetol (DRUG), Modafinil Placebo (DRUG), Solriamfetol Placebo (DRUG).

Who is sponsoring clinical trial NCT06404099?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06404099 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.