Clinical trial NCT00928655: Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude
Official title: Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: apnea
sleep
altitude
hypoxia
treatment
CPAP
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: sleep disordered breathing and oxygenation
timeFrame: day 2 and 3 at altitude
Secondary outcomes:
measure: sleep quality, vigilance, acute mountain sickness, blood pressure
timeFrame: day 2 and 3 at altitude
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre
Study officials:
affiliation: University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland
name: Konrad E Bloch, MD
role: STUDY_DIRECTOR
References:
citation: Latshang TD, Nussbaumer-Ochsner Y, Henn RM, Ulrich S, Lo Cascio CM, Ledergerber B, Kohler M, Bloch KE. Effect of acetazolamide and autoCPAP therapy on breathing disturbances among patients with obstructive sleep apnea syndrome who travel to altitude: a randomized controlled trial. JAMA. 2012 Dec 12;308(22):2390-8. doi: 10.1001/jama.2012.94847.
citation: Latshang TD, Bloch KE, Lynm C, Livingston EH. JAMA patient page. Traveling to high altitude when you have sleep apnea. JAMA. 2012 Dec 12;308(22):2418. doi: 10.1001/jama.2012.4097. No abstract available.
citation: Latshang TD, Bloch KE. How to treat patients with obstructive sleep apnea syndrome during an altitude sojourn. High Alt Med Biol. 2011 Winter;12(4):303-7. doi: 10.1089/ham.2011.1055.
citation: Stadelmann K, Latshang TD, Nussbaumer-Ochsner Y, Tarokh L, Ulrich S, Kohler M, Bloch KE, Achermann P. Impact of acetazolamide and CPAP on cortical activity in obstructive sleep apnea patients. PLoS One. 2014 Apr 7;9(4):e93931. doi: 10.1371/journal.pone.0093931. eCollection 2014.