Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT00714740

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Syndrome	Drug: acetazolamide	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness [during treatment while at altitude]

Secondary Outcome Measures

blood pressure endothelial function [during treatment while at altitude]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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