Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome

• Registration Number: NCT00714740
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of the study is to investigate the effect of 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-14
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-18
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Obstructive sleep apnea syndrome, successfully on CPAP therapy
• Residence at low altitude (<800m)
• 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

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Exclusion Criteria

• Sleep disorders other than OSA.
• More than mild cardiovascular disease, unstable or recently diagnosed (within the last 6 months) cardiovascular disease such as arterial hypertension, coronary artery or cerebrovascular 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 (<2600m).
• Exposure to altitudes >1500m for >1 day within the last 4 weeks before the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness	during treatment while at altitude

Secondary Outcome Measures

Name	Time	Method
blood pressure endothelial function	during treatment while at altitude

Trial Locations

Locations (1)

Pulmonary Division, University Hospital Zurich; 🇨🇭 Zurich, Switzerland