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

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ClinicalTrials.gov Identifier: NCT00928655
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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
Obstructive Sleep Apnea Syndrome Drug: acetazolamide Procedure: nocturnal continuous positive airway pressure Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
 Drug: acetazolamide
acetazolamide 250mg 1/0/2
Other Name: Diamox (trade name)
Procedure: nocturnal continuous positive airway pressure
continuous positive airway pressure
Other Name: 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 Name: placebo capsules
Drug: placebo
placebo capsules
Other Name: placebo capsules


Outcome Measures
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Primary Outcome Measures :
  1. sleep disordered breathing and oxygenation [ Time Frame: day 2 and 3 at altitude ]

Secondary Outcome Measures :
  1. sleep quality, vigilance, acute mountain sickness, blood pressure [ Time Frame: day 2 and 3 at altitude ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928655


Locations
Switzerland
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00928655     History of Changes
Other Study ID Numbers: EK-1522A#1-4
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by University of Zurich:
apnea
sleep
altitude
 hypoxia
treatment
CPAP

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs