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NCT03818581 · ClinicalTrials.gov registry record · Phase 4
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
A Phase 4 study of Insomnia and Inflammation, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT03818581: Completed Phase 4 study of Insomnia and Inflammation, sponsored by Massachusetts General Hospital.
NCT03818581 is a Phase 4 study of Insomnia and Inflammation that has completed, run by Massachusetts General Hospital. The registered enrollment target is 108 participants, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818581, a Phase 4 study of Insomnia and Inflammation, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized placebo-controlled trial for 3 months.
Primary Outcome
Total sleep time as reported on daily sleep diaries
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Suvorexant
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 4 |
What the finished NCT03818581 record still lists
NCT03818581 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (36% lower).
The record links to 4 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03818581 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03818581 about?
NCT03818581 is a clinical study titled "Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes". The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized placebo-controlled trial for 3 months.
What is the current status of trial NCT03818581?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2019-03-15. Estimated completion is 2021-11-03.
What conditions does trial NCT03818581 study?
This clinical trial studies the following conditions: Insomnia, Inflammation, Type 2 Diabetes Mellitus, Sleep Disorder.
What interventions are being tested in trial NCT03818581?
The interventions under investigation include: Placebo (OTHER), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT03818581?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03818581 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03818581's enrollment target sits among peer trials
108 59th of 151 higher than 93 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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