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OpenTrials
Completed

NCT Number: NCT00928655

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

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Hypoxia Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

acetazolamide 250mg 1/0/2

Other names: Diamox (trade name)

nocturnal continuous positive airway pressure

Procedure

continuous positive airway pressure

Other names: placebo capsules

Placebo

Drug

placebo capsules

Other names: placebo capsules

Primary outcomes

  1. sleep disordered breathing and oxygenation

    Time frame: day 2 and 3 at altitude

Secondary outcomes

  1. sleep quality, vigilance, acute mountain sickness, blood pressure

    Time frame: day 2 and 3 at altitude

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 26, 2009
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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