Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

NCT00714740 | Completed Phase 4

• 1 other identifier: EK-1522
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

apnea, sleep, altitude, hypoxia

Outcome Measures

Primary Outcomes (1)

• sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness

  during treatment while at altitude

Secondary Outcomes (1)

• blood pressure endothelial function

  during treatment while at altitude

Interventions

acetazolamide DRUG

acetazolamide 2 times 250mg per day

Also known as: Diamox

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Pulmonary Division, University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

Related 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):131-138. doi: 10.1378/chest.11-0375. Epub 2011 Jun 9.

  PMID: 21659435 BACKGROUND

• 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.

  PMID: 24811331 BACKGROUND

• 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.

  PMID: 24710341 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Hypoxia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konrad E Bloch, MD

  Pulmonary Division, University Hospital Zurich, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

CH (1)