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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT00928655
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
5
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: acetazolamide

combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

Drug: acetazolamide
acetazolamide 250mg 1/0/2
Other Names:
  • Diamox (trade name)

    • Procedure: nocturnal continuous positive airway pressure
    continuous positive airway pressure
    Other Names:
  • placebo capsules

    		•
    Placebo Comparator: placebo capsules

    combination of placebo and nocturnal continuous positive airway pressure ventilation

    Procedure: nocturnal continuous positive airway pressure
    continuous positive airway pressure
    Other Names:
  • placebo capsules

    • Drug: placebo
    placebo capsules
    Other Names:
  • placebo capsules

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sleep disordered breathing and oxygenation [day 2 and 3 at altitude]

    Secondary Outcome Measures

    1. sleep quality, vigilance, acute mountain sickness, blood pressure [day 2 and 3 at altitude]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre Zurich Switzerland CH-8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Study Director: Konrad E Bloch, MD, University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT00928655
    Other Study ID Numbers:
    • EK-1522A#1-4
    First Posted:
    Jun 26, 2009
    Last Update Posted:
    May 20, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by University of Zurich
    apnea
    sleep
    altitude
    hypoxia
    treatment
    CPAP
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Syndrome
    Acetazolamide

    Study Results

    No Results Posted as of May 20, 2014