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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

NCT00714740

Obstructive Sleep Apnea Syndrome

COMPLETED PHASE4

Study to Investigate Sleep Apnea Patients at Altitude

NCT00514826

Obstructive Sleep Apnea Syndrome

COMPLETED NA

Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

NCT02781740

Sleep Apnea, Obstructive

COMPLETED NA

Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

NCT01427192

Pulmonary Hypertension Breathing-Related Sleep Disorder

COMPLETED PHASE2

Breath Analysis in Obstructive Sleep Apnoea

NCT02050425

Obstructive Sleep Apnoea (OSA)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

acetazolamide

combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

Group Type EXPERIMENTAL

acetazolamide

Intervention Type DRUG

acetazolamide 250mg 1/0/2

nocturnal continuous positive airway pressure

Intervention Type PROCEDURE

continuous positive airway pressure

placebo capsules

combination of placebo and nocturnal continuous positive airway pressure ventilation

Group Type PLACEBO_COMPARATOR

nocturnal continuous positive airway pressure

Intervention Type PROCEDURE

continuous positive airway pressure

placebo

Intervention Type DRUG

placebo capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acetazolamide

acetazolamide 250mg 1/0/2

Intervention Type DRUG

nocturnal continuous positive airway pressure

continuous positive airway pressure

Intervention Type PROCEDURE

placebo

placebo capsules

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diamox (trade name) placebo capsules placebo capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No