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Sponsored by: |
Clayton Sleep Insititute |
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Information provided by: | Clayton Sleep Insititute |
ClinicalTrials.gov Identifier: | NCT00665977 |
Condition | Intervention | Phase |
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Obstructive Sleep Apnea Nasal Congestion Sinus Congestion |
Drug: Thermosmart & placebo Drug: Placebo Device & Nasacort Device: Placebo Arm |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure |
Estimated Enrollment: | 44 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Sham Comparator
To enter into the single-blind placebo phase, subjects will be setup with a Fisher & Paykel 604 CPAP unit with a heated humidifier and "deactivated" Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still "appear" to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily.
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Device: Placebo Arm
To enter into the single-blind placebo phase, subjects will be setup with a Fisher & Paykel 604 CPAP unit with a heated humidifier and "deactivated" Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still "appear" to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily.
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Double Blind Treatment Group 2: Active Comparator
Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher & Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
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Drug: Placebo Device & Nasacort
Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher & Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
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Double Blind Treatment Goup 1: Active Comparator
a Fisher & Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily
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Drug: Thermosmart & placebo
a Fisher & Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily
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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.
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Krista Russell, CCRC | 314-645-6005 | research@claytonsleep.com |
Contact: Research Coordinator | 314-645-6005 | research@claytonsleep.com |
United States, Missouri | |
Clayton Sleep Institute | Recruiting |
St. Louis, Missouri, United States, 63143 | |
Contact: Research Coordinator 314-645-6605 research@claytonsleep.com | |
Principal Investigator: Eric D Powell, PhD |
Responsible Party: | Clayton Sleep Institute, LLC ( Eric Powell, PhD ) |
Study ID Numbers: | F & P 07-004 |
Study First Received: | February 7, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00665977 |
Health Authority: | United States: Food and Drug Administration |
Obstructive Sleep Apnea Nasal Congestion Sinus congestion |
Sleep Apnea Syndromes Triamcinolone Acetonide Respiratory Tract Diseases Apnea Triamcinolone Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Triamcinolone diacetate Triamcinolone hexacetonide Sleep Disorders, Intrinsic |
Nervous System Diseases |