Long COVIDPhase 2NCT06404099

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

A Phase 2 study testing Modafinil and Solriamfetol in people with Long COVID and Long COVID-19, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Long COVID, Long COVID-19, Hypersomnia
What is being tested?: Modafinil and Solriamfetol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 361 participants
Where: 1 siteUnited States
Study dates: 12 Aug 2024to 20 Apr 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Who cannot join

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*

Show all 20Show fewer

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 CYP2C19. 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

Trial locations and contacts

1 site in 1 country.

United States1 site

All sites listed under NCT06404086
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

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).

Read the 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 placebo/control group.

Conditions: Long COVID, Long COVID-19, Hypersomnia
Being tested: Modafinil, Modafinil Placebo, Solriamfetol, Solriamfetol Placebo
Keywords: PASC
Medical subject headings: Post-Acute COVID-19 Syndrome, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ModafinilDrug
Modafinil is used off-label based on supporting published evidence in major depressive disorder (antidepressant augmentation), multiple sclerosis-related fatigue, Parkinson disease-related excessive daytime sleepiness, and severe cancer-related fatigue (in patients receiving active treatment). Doses up to 400 mg/day, given as a singleMode dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose.
Study drug administration will total 10 weeks.
Modafinil PlaceboDrug
The placebo will be tooled to look similar to the modafinil tablet, but it will not contain the active ingredient. Modafinil placebo dosing will follow the same titration scheme as modafinil treatment.
Unblinded study personnel will manage modafinil and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.
SolriamfetolDrug
The proposed doses and the schedule of dose escalation are consistent with currently approved FDA labeling for solriamfetol for other disorders of excessive daytime sleepiness.
Solriamfetol dosing will total 10 weeks, including 3 weeks for titration and 7 weeks of maintenance. Solriamfetol will be given as a 75 mg tablet (1 or 2 per day) in the morning. The 3-week titration will be facilitated by phone calls between the study team and participants. Titrations in dose will be dependent upon participants' symptoms and tolerance to solriamfetol, with a goal of participants taking the highest dose permitted by symptoms. This dose will be used for the maintenance phase.
Solriamfetol PlaceboDrug
The placebo tablet will be tooled to look similar to the solriamfetol tablet, but it will not contain the active ingredient. Solriamfetol placebo dosing will follow the solriamfetol dosing scheme and goal.
Unblinded study personnel will manage solriamfetol and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.

Study groups in NCT06404099
Study group	Role	What they receive
Wake-promoting drug: Modafinil or solriamfetol	Active comparator	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. Receives: Drug: Modafinil; Drug: Solriamfetol
Modafinil-matched placebo or solriamfetol-matched placebo	Placebo comparator	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. Receives: Drug: Modafinil Placebo; Drug: Solriamfetol Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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 a score of 55 being 1 standard deviation above population mean. Higher scores indicate greater sleep-related impairment.
Measured: Baseline, End of Intervention (Day 77)

Secondary outcomes (14)

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 > 55 1 SD above population mean.
Measured: Baseline, End of Intervention (Day 77)
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).
Measured: Baseline, End of Intervention (Day 77)
Change in an objective neurocognitive battery score
Measured: Baseline, End of Intervention (Day 77)
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.
Measured: Baseline, End of Intervention (Day 77)
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.
Measured: Baseline, End of Intervention (Day 77)
Change in total score on the Insomnia Severity Index (ISI)
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.
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary
Nocturnal sleep duration will be assessed by sleep diary
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker
Nocturnal sleep duration will be assessed by activity tracker
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)
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
Measured: Baseline, End of Intervention (Day 77)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202420 Apr 2026

First posted8 May 2024
Study start12 Aug 2024
Primary completion24 Mar 2026
Study completion20 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Long COVIDStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This platform protocol is designed to allocate participants into an intervention appendix based on their symptoms of sleep disturbance. Within the appendix, participants will be randomly assigned based on the appendix study design. Site investigators and personnel will be informed as to which study intervention appendix participants are assigned, but they will be blinded to whether participants are receiving the active study intervention or control, when possible. Similarly, participants will be blinded to active intervention or control, when possible. Randomization will be stratified by the study site; other stratification factors may be considered per appendix.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06404099
Sponsor's protocol ID: Pro00112484_A
Other IDs: OTA-21-015G
Status last verified: May 2026
First submitted: 6 May 2024
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The summary of results will be shared on the study website: https://recovercovid.org/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
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Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
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Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
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RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
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All Long COVID trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
ClinicalTrials.gov ID: NCT06404099
Acronym / sponsor ID: Pro00112484_A
Conditions: Long COVID, Long COVID-19, Hypersomnia
Keywords: PASC
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 12 Aug 2024 (actual)
Primary completion: 24 Mar 2026 (actual)
Study completion: 20 Apr 2026 (actual)
First posted: 8 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 placebo/control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This platform protocol is designed to allocate participants into an intervention appendix based on their symptoms of sleep disturbance. Within the appendix, participants will be randomly assigned based on the appendix study design. Site investigators and personnel will be informed as to which study intervention appendix participants are assigned, but they will be blinded to whether participants are receiving the active study intervention or control, when possible. Similarly, participants will be blinded to active intervention or control, when possible. Randomization will be stratified by the study site; other stratification factors may be considered per appendix.

Arm	Type	Receives
Wake-promoting drug: Modafinil or solriamfetol	Active comparator	Drug: Modafinil, Drug: SolriamfetolParticipants 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.
Modafinil-matched placebo or solriamfetol-matched placebo	Placebo comparator	Drug: Modafinil Placebo, Drug: Solriamfetol PlaceboParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

Key exclusion criteria (20 listed)

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)
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*

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ModafinilModafinil is used off-label based on supporting published evidence in major depressive disorder (antidepressant augmentation), multiple sclerosis-related fatigue, Parkinson disease-related excessive daytime sleepiness, and severe cancer-related fatigue (in patients receiving active treatment). Doses up to 400 mg/day, given as a singleMode dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose. Study drug administration will total 10 weeks.	Drug	Wake-promoting drug: Modafinil or solriamfetol
Modafinil PlaceboThe placebo will be tooled to look similar to the modafinil tablet, but it will not contain the active ingredient. Modafinil placebo dosing will follow the same titration scheme as modafinil treatment. Unblinded study personnel will manage modafinil and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.	Drug	Modafinil-matched placebo or solriamfetol-matched placebo
SolriamfetolThe proposed doses and the schedule of dose escalation are consistent with currently approved FDA labeling for solriamfetol for other disorders of excessive daytime sleepiness. Solriamfetol dosing will total 10 weeks, including 3 weeks for titration and 7 weeks of maintenance. Solriamfetol will be given as a 75 mg tablet (1 or 2 per day) in the morning. The 3-week titration will be facilitated by phone calls between the study team and participants. Titrations in dose will be dependent upon participants' symptoms and tolerance to solriamfetol, with a goal of participants taking the highest dose permitted by symptoms. This dose will be used for the maintenance phase.	Drug	Wake-promoting drug: Modafinil or solriamfetol
Solriamfetol PlaceboThe placebo tablet will be tooled to look similar to the solriamfetol tablet, but it will not contain the active ingredient. Solriamfetol placebo dosing will follow the solriamfetol dosing scheme and goal. Unblinded study personnel will manage solriamfetol and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators.	Drug	Modafinil-matched placebo or solriamfetol-matched placebo

Primary outcome

Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
Time frame: 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.

14 secondary outcomes

Change in total score of the PROMIS 8b SD to assess sleep disturbance
Time frame: Baseline, End of Intervention (Day 77)
Change in PROMIS 10a Fatigue score
Time frame: Baseline, End of Intervention (Day 77)
Change in an objective neurocognitive battery score
Time frame: Baseline, End of Intervention (Day 77)
Change in ECog2 measure
Time frame: Baseline, End of Intervention (Day 77)
Change in PASC Symptom Questionnaire responses
Time frame: Baseline, End of Intervention (Day 77)
Change in total score on the Insomnia Severity Index (ISI)
Time frame: Baseline, End of Intervention (Day 77)
Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 77)
Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker
Time frame: Baseline, End of Intervention (Day 77)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. The summary of results will be shared on the study website: https://recovercovid.org/

Related trials for Long COVID

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Enrolling by invitationPhase 2
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Active, not recruitingObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina Barkauskas, MD study chair

Duke Clinical Research Institute

Susan Redline, MD MPH study chair

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modafinil and Solriamfetol in people with Long COVID and Long COVID-19, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total score of the PROMIS 8a SRI to assess sleep-related impairment (time frame: Baseline, End of Intervention (Day 77)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06404099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.