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Clinical Trials/NCT00714740
NCT00714740
Completed
Phase 4

Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

University of Zurich1 site in 1 country49 target enrollmentStarted: June 2008Last updated:
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ConditionsObstructive Sleep Apnea Syndrome
Drugsacetazolamide

Overview

Phase
Phase 4
Status
Completed
Enrollment
49
Locations
1
Primary Endpoint
sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness

Time Frame: during treatment while at altitude

Secondary Outcomes

  • blood pressure endothelial function(during treatment while at altitude)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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