Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Drug: acetazolamide; Procedure: nocturnal continuous positive airway pressure; Drug: placebo

• Registration Number: NCT00928655
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-18
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
acetazolamide	nocturnal continuous positive airway pressure	combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
placebo capsules	nocturnal continuous positive airway pressure	combination of placebo and nocturnal continuous positive airway pressure ventilation
placebo capsules	placebo	combination of placebo and nocturnal continuous positive airway pressure ventilation
acetazolamide	acetazolamide	combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

Primary Outcome Measures

Name	Time	Method
sleep disordered breathing and oxygenation	day 2 and 3 at altitude

Secondary Outcome Measures

Name	Time	Method
sleep quality, vigilance, acute mountain sickness, blood pressure	day 2 and 3 at altitude

Trial Locations

Locations (1)

University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre; 🇨🇭 Zurich, Switzerland