Randomized Clinical Trial of Nasal Turbinate Reduction to Improve Continuous Positive Airway Pressure (CPAP) Outcomes for Sleep Apnea
Completed · Phase 2 · Has a placebo group
Conditions studied: Sleep Apnea Syndromes, Nasal Obstruction, Turbinate Hypertrophy
In brief
Obstructive sleep apnea occurs in 2-4% of middle age adults and results in significant morbidity and mortality. The first line therapy is provision of continuous positive airway pressure (CPAP) via a nasal mask chronically. Nasal resistance related to nasal turbinate enlargement may compromise CPAP treatment. This randomized double-blind sham-placebo-controlled trial tests the hypothesis that nasal turbinate reduction improves the nasal passage, CPAP use, and sleep apnea quality of life in newly diagnosed sleep apnea patients who are recommended CPAP therapy.
Key facts
- Study ID
- NCT00503802
- Run by
- University of Washington
- People needed
- 242
- Starts
- 2007-07-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-06-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-80 years
- Newly diagnosed obstructive sleep apnea (apnea-hypopnea index >= 5 events/hour)
- CPAP therapy recommended
- Persistent bilateral inferior turbinate hypertrophy
- American Society of Anesthesiologists Class I-III
- Ability to give informed consent
- Ability and willingness to complete the study protocol
- Fluency in verbal and written English
You may not qualify if…
- Previous surgical turbinate treatment
- Other nasal disorders (i.e. recurrent epistaxis, desiccated or crusted mucosa, severe bilateral obstructing septal deformity, or obstructing polyposis)
- Active respiratory tract infections
- Coagulopathy
- Severe psychiatric comorbidity (taking anti-psychotic medication)
- American Society of Anesthesiologists Class IV or V
- Pregnancy
- No telephone
- Plans of moving during the study period
- Known contraindication to lidocaine with epinephrine, oxymetazoline, or acetaminophen
Where it is running
- UW Sleep Disorders Center at Harborview Medical Center — Seattle, Washington, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
- University of Washington General Clinical Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.