Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude
Information source: University of Zurich
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea Syndrome
Intervention: acetazolamide (Drug); nocturnal continuous positive airway pressure (Procedure); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Zurich Official(s) and/or principal investigator(s):
Konrad E Bloch, MD, Study Director, Affiliation: University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland
Overall contact:
Konrad E Bloch, MD, Phone: 41442553828, Email: konrad.bloch@usz.ch
Summary
The purpose of the study is to investigate the effect of nasal continuous positive airway
pressure in combination with acetazolamide as a treatment for sleep related breathing
disturbances in patients with the obstructive sleep apnea syndrome living at low altitude
during a sojourn at moderate altitude.
Clinical Details
Official title: Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: sleep disordered breathing and oxygenation
Secondary outcome: sleep quality, vigilance, acute mountain sickness, blood pressure
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Obstructive sleep apnea syndrome, successfully on CPAP therapy
- Residence at low altitude (< 800 m)
- Obstructive apnea/hypopnea index >20/h and a complaint of excessive daytime
sleepiness before introduction of CPAP therapy
- > 15 oxygen desaturations/h (> 3% dips) during an ambulatory nocturnal pulse oximetry
performed at the end of a 4-night period without CPAP
Exclusion Criteria:
- Sleep disorders other than OSA
- More than mild cardiovascular disease, unstable cardiovascular disease
- Any lung disease, pulmonary hypertension
- Chronic rhinitis
- Treatment with drugs that affect respiratory center drive (benzodiazepines or other
sedatives or sleep inducing drugs, morphine or codeine derivates), stimulants
(modafinil, methylphenidate, theophylline)
- Internal, neurologic or psychiatric disease that interfere with sleep quality
- Previous intolerance to moderate or low altitude (< 2600 m)
- Exposure to altitudes > 1500m for > 1 day within the last 4 weeks before the study
Locations and Contacts
Konrad E Bloch, MD, Phone: 41442553828, Email: konrad.bloch@usz.ch
University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich CH-8091, Switzerland; Recruiting
Konrad E Bloch, MD, Phone: 0041442553828, Email: konrad.bloch@usz.ch
Konrad E Bloch, MD, Principal Investigator
Tsogyal Latshang, MD, Sub-Investigator
Additional Information
Starting date: June 2009
Ending date: November 2009
Last updated: July 7, 2009
|
