Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal

Status Completed

Clinical Trial 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.

Clinical Trial Description

Eligible participants will undergo this double-blind, placebo controlled, single-blind double placebo run-in, crossover trial to determine the efficacy of heated humidity with Thermosmart™ in improving compliance and nasal symptoms in patients using CPAP versus a nasal steroid and placebo (heated humidity, nasal steroid placebo) phases. After successful screening, participants will undergo a two week single-blind double placebo run-in phase using heated humidity and a nasal steroid placebo. The double-blind treatment phase will last a total of six weeks. Participants will undergo both phases: three weeks using heated humidity with Thermosmart™ and nasal steroid placebo and three weeks using a nasal steroid with a heated humidifier. Treatment phases will be counterbalanced. Study participation will last a total of 8 weeks from screening to completion of double-blind treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00665977
Study type	Interventional
Source	Clayton Sleep Insititute
Contact
Status	Completed
Phase	Phase 3
Start date	September 2007
Completion date	July 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure — Thermosmart

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms