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NCT00665977 · ClinicalTrials.gov registry record · Phase 3
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
A Phase 3 study of Obstructive Sleep Apnea and Nasal Congestion, sponsored by Clayton Sleep Insititute.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT00665977: Completed Phase 3 study of Obstructive Sleep Apnea and Nasal Congestion, sponsored by Clayton Sleep Insititute.
NCT00665977 is a Phase 3 study of Obstructive Sleep Apnea and Nasal Congestion that has completed, run by Clayton Sleep Insititute. The registered enrollment target is 44 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665977, a Phase 3 study of Obstructive Sleep Apnea and Nasal Congestion, has completed, sponsored by Clayton Sleep Insititute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 3. Improvement in nasal symptoms in using CPAP will be significantly improved in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase, and comparable between the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 4. Secondary to improvements in CPAP compliance, measures of daytime functioning and quality of life will improve in the heated humidity with Thermosmart™ versus double placebo.
Conditions Studied
Interventions
- DRUG Thermosmart & placebo
- DRUG Placebo Device & Nasacort
- DEVICE Placebo Arm
Study Locations (1)
Missouri
- Clayton Sleep Institute - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00665977 record still lists
NCT00665977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 3 interventions - of which Thermosmart & placebo is the first listed.
NCT00665977 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT00665977 about?
NCT00665977 is a clinical study titled "Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure". 1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 3. Improvemen...
What is the current status of trial NCT00665977?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2007-09. Estimated completion is 2010-07.
What conditions does trial NCT00665977 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion.
What interventions are being tested in trial NCT00665977?
The interventions under investigation include: Thermosmart & placebo (DRUG), Placebo Device & Nasacort (DRUG), Placebo Arm (DEVICE).
Who is sponsoring clinical trial NCT00665977?
This trial is sponsored by Clayton Sleep Insititute, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00665977 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00665977's enrollment target sits among peer trials
44 111th of 155 higher than 45 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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.
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