Sleep ApneaNCT02670096
A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
A study testing Acetazolamide in people with Sleep Apnea, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 to 80 years
- TE-CSA
- Subjects are capable of giving informed consent
Who cannot join
- Hypersensitivity to acetazolamide or other sulfonamides
- Intake of carbonic anhydrase inhibitors within the last 72 hours
- Intake of medication that influences breathing, sleep, arousal or muscle physiology
- Cheyne-Stokes respiration
- Heart failure
- Renal failure
Show all 13Show fewer
- Liver failure
- Chronic hypercapnea
- Hyponatremia
- Hypokalemia
- Pregnancy
- Breastfeeding mothers
- Active drug/alcohol dependence or abuse history
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. The purpose of this study is to assess the immediate effect one-time low-dose acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will also try to determine the immediate effect of one-time low-dose acetazolamide on subjects' resting ventilation and ventilatory response slope compared to subjects' baseline evaluation without acetazolamide.
- Conditions
- Sleep Apnea
- Being tested
- Acetazolamide
- Keywords
- acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)
| Study group | Role | What they receive |
|---|---|---|
| Reference therapy | Experimental | * Baseline evaluation of subjects without acetazolamide administration
* Follow up evaluation of subjects one hour after acetazolamide administration Receives: Drug: Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
Measured: 60 Days
Total lung capacity before and after acetazolamide administration
Measured: 60 Days
Secondary outcomes (4)
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
Measured: 20 Minutes
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
Measured: 15 Minutes
Measurement of Arterial Blood Gas (ABG)
Measured: 60 Days
Measurement of Venous Blood (VB) Analysis
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rapoport, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670096
- Sponsor's protocol ID
- 15-00756
- Status last verified
- Jan 2017
- First submitted
- 21 Jan 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT02670096
- Acronym / sponsor ID
- 15-00756
- Conditions
- Sleep Apnea
- Keywords
- acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Feb 2016 (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 is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. The purpose of this study is to assess the immediate effect one-time low-dose acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will also try to determine the immediate effect of one-time low-dose acetazolamide on subjects' resting ventilation and ventilatory response slope compared to subjects' baseline evaluation without acetazolamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reference therapy | Experimental | Drug: Acetazolamide* Baseline evaluation of subjects without acetazolamide administration * Follow up evaluation of subjects one hour after acetazolamide administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 to 80 years
- TE-CSA
- Subjects are capable of giving informed consent
Key exclusion criteria (13 listed)
- Hypersensitivity to acetazolamide or other sulfonamides
- Intake of carbonic anhydrase inhibitors within the last 72 hours
- Intake of medication that influences breathing, sleep, arousal or muscle physiology
- Cheyne-Stokes respiration
- Heart failure
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: DiamoxTwo single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing) | Drug | Reference therapy |
Primary outcome
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
Time frame: 60 Days
Total lung capacity before and after acetazolamide administration
Time frame: 60 Days
4 secondary outcomes
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
Time frame: 20 Minutes
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
Time frame: 15 Minutes
Measurement of Arterial Blood Gas (ABG)
Time frame: 60 Days
Measurement of Venous Blood (VB) Analysis
Time frame: 60 Days
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 24 Jan 2017.
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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.
David Rapoport, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetazolamide in people with Sleep Apnea, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 13 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 24 Jan 2017. 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 United States. 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. 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.
What does the primary outcome measure?
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography (time frame: 60 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Jan 2017.