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

May 18, 2014 updated by: University of Zurich

Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Drug: placebo
placebo capsules
Other Names:
  • placebo capsules
Procedure: nocturnal continuous positive airway pressure
continuous positive airway pressure
Other Names:
  • placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sleep disordered breathing and oxygenation
Time Frame: day 2 and 3 at altitude
day 2 and 3 at altitude

Secondary Outcome Measures

Outcome Measure
Time Frame
sleep quality, vigilance, acute mountain sickness, blood pressure
Time Frame: day 2 and 3 at altitude
day 2 and 3 at altitude

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 18, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-1522A#1-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea Syndrome

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe