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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Drug: placebo; Procedure: nocturnal continuous positive airway pressure; Drug: acetazolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00928655

EK-1522A#1-4

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

acetazolamide

Experimental group

Description:

combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

Treatment:

Procedure: nocturnal continuous positive airway pressure

Drug: acetazolamide

placebo capsules

Placebo Comparator group

Description:

combination of placebo and nocturnal continuous positive airway pressure ventilation

Treatment:

Procedure: nocturnal continuous positive airway pressure

Drug: placebo