Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Overview
- Phase
- Phase 4
- Intervention
- acetazolamide
- Conditions
- Obstructive Sleep Apnea Syndrome
- Sponsor
- University of Zurich
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- sleep disordered breathing and oxygenation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
Intervention: acetazolamide
acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
Intervention: nocturnal continuous positive airway pressure
placebo capsules
combination of placebo and nocturnal continuous positive airway pressure ventilation
Intervention: nocturnal continuous positive airway pressure
placebo capsules
combination of placebo and nocturnal continuous positive airway pressure ventilation
Intervention: placebo
Outcomes
Primary Outcomes
sleep disordered breathing and oxygenation
Time Frame: day 2 and 3 at altitude
Secondary Outcomes
- sleep quality, vigilance, acute mountain sickness, blood pressure(day 2 and 3 at altitude)