Trial · NCT03626727
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
NCT03626727, Early phase 1, Withdrawn, Brigham and Women's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia. Trials, record NCT03626727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03626727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
- NCT number
- NCT03626727
- Status
- Withdrawn
- Phases
- Early phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Hypersomnia, Narcolepsy, Traumatic Brain Injury
- Interventions
- Sodium Oxybate Oral Solution [Xyrem]
- First posted
- 2018-08-13
- Last updated
- 2021-03-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Subjective Daytime Sleepiness | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in subjective daytime sleepiness assessed through a daily questionnaire about frequency and duration of daytime naps, frequency of sleep attacks. |
| Primary | Change in Sleep Duration | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in sleep duration assessed by actigraphy-estimated total sleep time (TST). |
| Primary | Change in Clinical Condition | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in clinical condition as assessed by Clinical Global Impression (CGI) assessment. CGI assesses a clinician's view of a patient's global functioning before and after initiating medication. It is broken up into CGI-S (Severity) and CGI-I (Improvement). CGI-S is one question assesses how clinically ill a patient is at time of assessment. it is on a 1-7 scale with 1 being normal and 7 being among the most extremely ill patients. CGI-I looks at improvement in patients functioning once medication starts. it is also on a 1-7 scale with 1 being very much improved since initiation of treatment and 7 being very much worse. |
| Primary | Change in Subjective Daytime Sleepiness (ESS) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Change in daytime sleepiness will be assessed through changes in Epworth Sleepiness Scale (ESS) scores. The ESS measures sleepiness of a participant. It is eight questions with a scale of 0 - 3 with 0 being no chance of dozing and 3 being high chance of dozing. The total score of eight questions is reported. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of nocturnal awakenings) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of nocturnal awakenings. |
| Secondary | Change in Nocturnal Sleep Quality (Duration of nocturnal awakenings) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on duration of nocturnal awakenings. |
| Secondary | Change in Nocturnal Sleep Quality (Subjective amount of sleep) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on subjective amount of sleep each night. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of sleep walking) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of sleep walking. |
| Secondary | Change in Nocturnal Sleep Quality (Frequency of hypnagogic hallucinations) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by a daily sleep questionnaire on frequency of hypnagogic hallucinations. |
| Secondary | Change in Nocturnal Sleep Quality (Change in Pittsburgh Sleep Quality index) scores) | Data collected on Day 1 (Baseline Visit) of the Intervention and at end of 1 week on the final dosage, which will be 2-5 weeks after the Baseline Visit. | Average change in nocturnal sleep quality assessed by changes in Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI assesses sleep quality. It is broken down into seven components, with scales from 0 - 3 with 0 being better quality of sleep and 3 being a more poor quality of sleep. The Global PSQI score is taken from the sum of the seven component scores. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03626727
GET https://conductscience.org/api/trials/v1/NCT03626727/registered