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Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00714740
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE July 8, 2008
First Posted Date  ICMJE July 14, 2008
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness [ Time Frame: during treatment while at altitude ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
blood pressure endothelial function [ Time Frame: during treatment while at altitude ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Official Title  ICMJE Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Brief Summary The purpose of the study is to investigate the effect of 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea Syndrome
Intervention  ICMJE Drug: acetazolamide
acetazolamide 2 times 250mg per day
Other Name: Diamox
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2014)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2008)
50
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obstructive sleep apnea syndrome, successfully on CPAP therapy
  • Residence at low altitude (<800m)
  • 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 or recently diagnosed (within the last 6 months) cardiovascular disease such as arterial hypertension, coronary artery or cerebrovascular 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 (<2600m).
  • Exposure to altitudes >1500m for >1 day within the last 4 weeks before the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00714740
Other Study ID Numbers  ICMJE EK-1522
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Konrad E Bloch, MD Pulmonary Division, University Hospital Zurich, Switzerland
PRS Account University of Zurich
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP