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
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
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
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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