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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 is a NA study that has completed, run by Cereve. The registered enrollment target is 30 participants.
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.
Interventions
- DEVICE Cereve Sleep System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01882699
The ClinicalTrials.gov registry entry for NCT01882699 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cereve, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cereve Sleep System is the first listed.
NCT01882699 reports 0 study locations.
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.
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