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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00928655
First received: June 22, 2009
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • sleep disordered breathing and oxygenation [ Time Frame: day 2 and 3 at altitude ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleep quality, vigilance, acute mountain sickness, blood pressure [ Time Frame: day 2 and 3 at altitude ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Konrad E. Bloch, Professor, MD, University Hospital of Zurich, Switzerland
ClinicalTrials.gov Identifier: NCT00928655     History of Changes
Other Study ID Numbers: EK-1522A#1-4
Study First Received: June 22, 2009
Last Updated: May 25, 2010
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Acetazolamide
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013