An interventional study of Transcranial Direct Current Stimulation and Sham stimulation in Hypersomnia, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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Among 100 studies in Disorders of Excessive Somnolence with a site in United States — 17 open to participants now, 20 under way, 11 of them phase 3. Disorders of Excessive Somnolence · United States.
Among the 100 studies in Disorders of Excessive Somnolence with a site in United States, this one is the 67th largest by enrollment of the 93 interventional ones that give a count, is one of 5 that started in 2017, is one of 31 with no phase, and was the 45th registered.
196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
Browse Disorders of Excessive Somnolence studies →17 of the 100 studies in Disorders of Excessive Somnolence with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+
Alkermes, Inc. · Sites in United States
Ages 18–65
Suven Life Sciences Limited · Sites in United States
Ages 18+
Alkermes, Inc. · Sites in United States, Belgium, Canada and 2 more countries
Ages 18–70
Centessa Pharmaceuticals (UK) Limited · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
100 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 20 · Phase 3 27 · Phase 4 12
First in 1996; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 39 is below the median of 86 across 158 interventional studies indexed under Disorders of Excessive Somnolence.
Median enrollment 70 across the 93 interventional studies, 83 across the 7 observational. Of the 75 that completed or were terminated, 38 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 100 have an industry lead sponsor. The 10 most frequent:
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Ohio State University has 1 study filed under Disorders of Excessive Somnolence — fewer than ten, so there is no comparison to draw.
11 of the studies in Disorders of Excessive Somnolence with a site in United States that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07540897Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) | 2027-06 |
Add all 11 to your calendar (.ics) → With an account.
Among the 100 studies in Disorders of Excessive Somnolence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized, sham-controlled, parallel group study. The study will last up to 5 weeks. After informed consent, subjects with idiopathic hypersomnia with an MSLT mean sleep latency of >8 minutes will undergo actigraphy and those with an average sleep time of >10 hours per day will continue with the study while those with \<10 hours sleep time will be excluded. In addition, OSA subjects with complaints of hypersomnia with an ESS score \<10 will also be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed as pregnancy is an exclusionary criteria.
Subjects will be randomized to receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. The randomization will be generated by means of a computer-generated random-number table. An unrestricted randomization scheme will be followed. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments. The investigator who will conduct the analysis of all outcomes will be blinded as to subject treatment assignment.
All stimulation visits will be completed within a five-consecutive day period; that is one stimulation visit may be missed provided a total of four stimulation visits are completed within a five-day period. Outcome measures will include: psychomotor vigilance test (PVT), subjective measures of sleepiness, and the Center for Epidemiologic Studies Depression (CES-D) scale. PVT will be performed pre- and post- stimulation during the first and last stimulation sessions. Subjective measures of sleepiness include the following: Epworth Sleepiness Scale (ESS), Stanford Sleepiness Scale (SSS), Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and Visual Analogue Scale (VAS).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of any of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active tDCS for 30 minutes daily for 4 sessions
Device: Transcranial Direct Current Stimulation
Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.
Device: Sham stimulation
tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.
Also known as: tDCS
Sham stimulation
Psychomotor Vigilance Test
Objective measure of sleepiness.
Time frame: 10 minutes
Epworth Sleepiness Scale
Subjective measure of sleepiness
Time frame: 5 minutes
Stanford Sleepiness Scale
Subjective measure of sleepiness
Time frame: 5 minutes
Functional Outcomes of Sleep Questionnaire
Measure of the impact of sleepiness on daytime function
Time frame: 5 minutes
Visual Analogue Scale
Subjective Measure of Sleepiness
Time frame: 5 minutes
CES-D Scale
Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: 5 minutes
| Milestone | Transcranial Direct Current Stimulation | Sham Stimulation |
|---|---|---|
| Started | 19 | 19 |
| Completed | 19 | 19 |
| Not completed | 0 | 0 |
Objective measure of sleepiness.
No measurements were reported for this outcome.
Subjective measure of sleepiness
No measurements were reported for this outcome.
Subjective measure of sleepiness
No measurements were reported for this outcome.
Measure of the impact of sleepiness on daytime function
No measurements were reported for this outcome.
Subjective Measure of Sleepiness
No measurements were reported for this outcome.
Center for Epidemiologic Studies Depression (CES-D) Scale
No measurements were reported for this outcome.
Collected over Adverse events were assessed through study completion (5 weeks for each participant).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcranial Direct Current Stimulation | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Sham Stimulation | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Mean | 38.63 ± 11.34 | 38.84 ± 14.27 | 38.73 ± 25.61 |
| Sex: Female, Male(Participants) | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 9 | 7 | 16 |
| Race (NIH/OMB)(Participants) | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 15 | 15 | 30 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
| BMI(kg/m^2) | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Mean | 29.70 ± 5.02 | 29.84 ± 6.67 | 29.77 ± 5.26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Jun 2020, 33 months.
Results were first posted in Oct 2021, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Disorders of Excessive Somnolence →