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NCT01882699 · ClinicalTrials.gov registry record · NA
30 Days in Home Use and Home Use Patterns Over 6 Months
A NA study, sponsored by Cereve.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01882699: Completed NA study, sponsored by Cereve.
NCT01882699 is a NA study that has completed, run by Cereve. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01882699, a NA study, has completed, sponsored by Cereve.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will build upon a previously approved protocol entitled "A multi-center prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two different temperatures in primary insomnia patients" (CIP-003; CER1-01-090). In that study, 150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab study will be enrolled to complete 2 phases of in home use of the device. In the first phase, the durability study, 30 patients are targeted to complete additional in lab assessments following 30 days of in home use of the device. In the second phase, the home use pattern study, 24 patients are targeted to complete an additional 5 months of in home use in which their use patterns will be monitored. Hypothesis: EEG sleep latency and sleep efficiency following 30 days in home use of the device at 14-16°C will be similar to those measures after the initial acute, 2-night use in the parent study in the 14-16°C condition. The device will demonstrate a benign safety profile over 6 months in home use.
Primary Outcome
latency from time in bed to persistent sleep
Interventions
- DEVICE Cereve Sleep System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01882699 record still lists
NCT01882699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cereve Sleep System is the first listed.
NCT01882699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01882699 about?
NCT01882699 is a clinical study titled "30 Days in Home Use and Home Use Patterns Over 6 Months". This study will build upon a previously approved protocol entitled "A multi-center prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two different temperatures in primary insomnia patients" (CIP-003; CER1-01-090). In that study, 150 insomnia patients were targete...
What is the current status of trial NCT01882699?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2013-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01882699?
The interventions under investigation include: Cereve Sleep System (DEVICE).
Who is sponsoring clinical trial NCT01882699?
This trial is sponsored by Cereve, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01882699's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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