Obstructive Sleep Apnea SyndromePhase 4NCT00928655
Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude
A Phase 4 study testing acetazolamide and nocturnal continuous positive airway pressure in people with Obstructive Sleep Apnea Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- acetazolamide and nocturnal continuous positive airway pressure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre
Zurich, CH-8091
About this study
Official title: Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- acetazolamide, nocturnal continuous positive airway pressure, placebo
- Keywords
- apnea, sleep, altitude, hypoxia, treatment, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
Also called Diamox (trade name)
acetazolamide 250mg 1/0/2
nocturnal continuous positive airway pressureProcedure or surgery
Also called placebo capsules
continuous positive airway pressure
placeboDrug
Also called placebo capsules
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| acetazolamide | Experimental | combination of acetazolamide and nocturnal continuous positive airway pressure ventilation Receives: Drug: acetazolamide; Procedure: nocturnal continuous positive airway pressure |
| placebo capsules | Placebo comparator | combination of placebo and nocturnal continuous positive airway pressure ventilation Receives: Procedure: nocturnal continuous positive airway pressure; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep disordered breathing and oxygenation
Measured: day 2 and 3 at altitude
Secondary outcomes (1)
sleep quality, vigilance, acute mountain sickness, blood pressure
Measured: day 2 and 3 at altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study director, University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928655
- Sponsor's protocol ID
- EK-1522A#1-4
- Status last verified
- May 2014
- First submitted
- 22 Jun 2009
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23232895Latshang 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.
PubMed 23232901Latshang 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.
PubMed 22206552Stadelmann 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.
PubMed 24710341
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
- ClinicalTrials.gov ID
- NCT00928655
- Acronym / sponsor ID
- EK-1522A#1-4
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- apnea, sleep, altitude, hypoxia, treatment, CPAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetazolamide | Experimental | Drug: acetazolamide, Procedure: nocturnal continuous positive airway pressurecombination of acetazolamide and nocturnal continuous positive airway pressure ventilation |
| placebo capsules | Placebo comparator | Procedure: nocturnal continuous positive airway pressure, Drug: placebocombination of placebo and nocturnal continuous positive airway pressure ventilation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetazolamideAlso: Diamox (trade name)acetazolamide 250mg 1/0/2 | Drug | acetazolamide |
| nocturnal continuous positive airway pressureAlso: placebo capsulescontinuous positive airway pressure | Procedure or surgery | acetazolamide, placebo capsules |
| placeboAlso: placebo capsulesplacebo capsules | Drug | placebo capsules |
Primary outcome
sleep disordered breathing and oxygenation
Time frame: day 2 and 3 at altitude
1 secondary outcome
sleep quality, vigilance, acute mountain sickness, blood pressure
Time frame: day 2 and 3 at altitude
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Background: PubMed 23232895Latshang 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.
- Background: PubMed 23232901Latshang 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.
- Background: PubMed 22206552Latshang 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.
- Background: PubMed 24710341Stadelmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, MD study director
University Hospital of Zurich, Pulmonary Division and Sleep Disorders Centre, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetazolamide and nocturnal continuous positive airway pressure in people with Obstructive Sleep Apnea Syndrome, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep disordered breathing and oxygenation (time frame: day 2 and 3 at altitude). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928655, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.