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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
acetazolamide
nocturnal continuous positive airway pressure
placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acetazolamide

placebo capsules

Arm Description

combination of acetazolamide and nocturnal continuous positive airway pressure ventilation

combination of placebo and nocturnal continuous positive airway pressure ventilation

Outcomes

Primary Outcome Measures

sleep disordered breathing and oxygenation

Secondary Outcome Measures

sleep quality, vigilance, acute mountain sickness, blood pressure

Full Information

First Posted
June 22, 2009
Last Updated
May 18, 2014
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00928655
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

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, treatment, CPAP

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
acetazolamide
Arm Type
Experimental
Arm Description
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
Arm Title
placebo capsules
Arm Type
Placebo Comparator
Arm Description
combination of placebo and nocturnal continuous positive airway pressure ventilation
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Other Intervention Name(s)
Diamox (trade name)
Intervention Description
acetazolamide 250mg 1/0/2
Intervention Type
Procedure
Intervention Name(s)
nocturnal continuous positive airway pressure
Other Intervention Name(s)
placebo capsules
Intervention Description
continuous positive airway pressure
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo capsules
Intervention Description
placebo capsules
Primary Outcome Measure Information:
Title
sleep disordered breathing and oxygenation
Time Frame
day 2 and 3 at altitude
Secondary Outcome Measure Information:
Title
sleep quality, vigilance, acute mountain sickness, blood pressure
Time Frame
day 2 and 3 at altitude

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
23232895
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.
Results Reference
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PubMed Identifier
23232901
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.
Results Reference
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PubMed Identifier
22206552
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.
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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Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude

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