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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 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.

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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

Obstructive Sleep Apnea Nasal Congestion Sinus Congestion

Interventions

  • DRUG Thermosmart & placebo
  • DRUG Placebo Device & Nasacort
  • DEVICE Placebo Arm

Study Locations (1)

Missouri

  • Clayton Sleep Institute - St Louis

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2007-09
Est. Completion 2010-07
Phase Phase 3

Sponsor

Clayton Sleep Insititute

3 total trials

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What the Registry Record Tells You About NCT00665977

The ClinicalTrials.gov registry entry for NCT00665977 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (80% lower). The listed sponsor is Clayton Sleep Insititute, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.