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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00928655
First received: June 22, 2009
Last updated: May 18, 2014
Last verified: May 2014

June 22, 2009
May 18, 2014
June 2009
November 2009   (final data collection date for primary outcome measure)
sleep disordered breathing and oxygenation [ Time Frame: day 2 and 3 at altitude ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928655 on ClinicalTrials.gov Archive Site
sleep quality, vigilance, acute mountain sickness, blood pressure [ Time Frame: day 2 and 3 at altitude ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
  • 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
  • Drug: placebo
    placebo capsules
    Other Name: placebo capsules
  • Experimental: acetazolamide
    combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
    Interventions:
    • Drug: acetazolamide
    • Procedure: nocturnal continuous positive airway pressure
  • Placebo Comparator: placebo capsules
    combination of placebo and nocturnal continuous positive airway pressure ventilation
    Interventions:
    • Procedure: nocturnal continuous positive airway pressure
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00928655
EK-1522A#1-4
Yes
University of Zurich
University of Zurich
Not Provided
Study Director: Konrad E Bloch, MD University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland
University of Zurich
May 2014

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