Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714740
• Other study ID #: EK-1522
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2008
• Last updated: May 18, 2014
• Start date: June 2008
• Est. completion date: December 2008

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 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: 49
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Obstructive sleep apnea syndrome, successfully on CPAP therapy

• Residence at low altitude (<800m)

• 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 or recently diagnosed (within the last 6 months) cardiovascular disease such as arterial hypertension, coronary artery or cerebrovascular 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 (<2600m).

• 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 2 times 250mg per day

Locations

Country	Name	City	State
Switzerland	Pulmonary Division, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Nussbaumer-Ochsner Y, Latshang TD, Ulrich S, Kohler M, Thurnheer R, Bloch KE. Patients with obstructive sleep apnea syndrome benefit from acetazolamide during an altitude sojourn: a randomized, placebo-controlled, double-blind trial. Chest. 2012 Jan;141(1):131-8. doi: 10.1378/chest.11-0375. Epub 2011 Jun 9. — 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

Ulrich S, Nussbaumer-Ochsner Y, Vasic I, Hasler E, Latshang TD, Kohler M, Muehlemann T, Wolf M, Bloch KE. Cerebral oxygenation in patients with OSA: effects of hypoxia at altitude and impact of acetazolamide. Chest. 2014 Aug;146(2):299-308. doi: 10.1378/chest.13-2967. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness		during treatment while at altitude	No
Secondary	blood pressure endothelial function		during treatment while at altitude	No