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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928655

Enrollment

Registered

2009-06-26

Start date

2009-06-30

Completion date

2009-11-30

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

apnea, sleep, altitude, hypoxia, treatment, CPAP

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.

Interventions

DRUGacetazolamide

acetazolamide 250mg 1/0/2

PROCEDUREnocturnal continuous positive airway pressure

continuous positive airway pressure

DRUGplacebo

placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
sleep disordered breathing and oxygenation	day 2 and 3 at altitude

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026