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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea Syndrome | Drug: acetazolamide Procedure: nocturnal continuous positive airway pressure Drug: placebo | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
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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 |
- sleep disordered breathing and oxygenation [ Time Frame: day 2 and 3 at altitude ]
- sleep quality, vigilance, acute mountain sickness, blood pressure [ Time Frame: day 2 and 3 at altitude ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
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

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
Switzerland | |
University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre | |
Zurich, Switzerland, CH-8091 |
Study Director: | Konrad E Bloch, MD | University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00928655 |
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 |
apnea sleep altitude |
hypoxia treatment CPAP |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Syndrome Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory 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 |