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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928655
• Other study ID #: EK-1522A#1-4
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2009
• Last updated: May 18, 2014
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Drug:
• acetazolamide
acetazolamide 250mg 1/0/2

Procedure:
• nocturnal continuous positive airway pressure
continuous positive airway pressure

Drug:
• placebo
placebo capsules

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep disordered breathing and oxygenation		day 2 and 3 at altitude	No
Secondary	sleep quality, vigilance, acute mountain sickness, blood pressure		day 2 and 3 at altitude	No