Sleep Apnea, ObstructiveNCT00108602
Sleep Apnea: Mechanism and Cerebrovascular Consequences
A study testing acetazolamide in people with Sleep Apnea, Obstructive and Stroke, run by US Department of Veterans Affairs.
Trial summary
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Stroke
- What is being tested?
- acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2007to May 2007
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will select non-obese patients (body mass index [BMI] <30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index [AHI] >15 events/hr of study time).
- Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale < 3)
Who cannot join
- Hemorrhagic stroke,
- A history of chronic obstructive lung disease,
- Left ventricular ejection fraction (LVEF) <55%
- Evidence of nasal or pharyngeal obstruction on physical examination.
About this study
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.
Read the detailed description
This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.
- Conditions
- Sleep Apnea, Obstructive, Stroke
- Being tested
- acetazolamide
- Keywords
- sleep apnea, stroke, ventilatory control
- Medical subject headings
- Sleep Apnea, Obstructive, Stroke, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: acetazolamide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startMay 2007
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: This study of the overall grant was not pursued as the aims were changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Steven Barczi, MD, Principal investigator, Wlliam S. Middleton Memorial Veterans Hospital, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108602
- Sponsor's protocol ID
- RESP-017-03S
- Status last verified
- Jun 2015
- First submitted
- 15 Apr 2005
- Last updated
- 26 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea: Mechanism and Cerebrovascular Consequences
- ClinicalTrials.gov ID
- NCT00108602
- Acronym / sponsor ID
- RESP-017-03S
- Conditions
- Sleep Apnea, Obstructive, Stroke
- Keywords
- sleep apnea, stroke, ventilatory control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study of the overall grant was not pursued as the aims were changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 18 Apr 2005 (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.
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.
Detailed description
This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: acetazolamide |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- We will select non-obese patients (body mass index [BMI] <30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index [AHI] >15 events/hr of study time).
- Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale < 3)
Key exclusion criteria (4 listed)
- Hemorrhagic stroke,
- A history of chronic obstructive lung disease,
- Left ventricular ejection fraction (LVEF) <55%
- Evidence of nasal or pharyngeal obstruction on physical examination.
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 |
|---|---|---|
| acetazolamide | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Steven Barczi, MD principal investigator
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Questions about this trial
What is this clinical trial studying?
A study testing acetazolamide in people with Sleep Apnea, Obstructive and Stroke, run by US Department of Veterans Affairs.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 26 Jun 2015.