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Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
acetazolamide
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring apnea, sleep, altitude, hypoxia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Division, University Hospital Zurich

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood pressure endothelial function

Full Information

First Posted
July 8, 2008
Last Updated
May 18, 2014
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00714740
Brief Title
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Official Title
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
apnea, sleep, altitude, hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
acetazolamide 2 times 250mg per day
Primary Outcome Measure Information:
Title
sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness
Time Frame
during treatment while at altitude
Secondary Outcome Measure Information:
Title
blood pressure endothelial function
Time Frame
during treatment while at altitude

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
Pulmonary Division, University Hospital Zurich, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Division, University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21659435
Citation
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.
Results Reference
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PubMed Identifier
24811331
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.
Results Reference
background
PubMed Identifier
24710341
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.
Results Reference
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Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude

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