A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
1 other identifier
interventional
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
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Started Jan 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 24, 2017
January 1, 2017
11 months
January 21, 2016
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
60 Days
Total lung capacity before and after acetazolamide administration
60 Days
Secondary Outcomes (4)
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
20 Minutes
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
15 Minutes
Measurement of Arterial Blood Gas (ABG)
60 Days
Measurement of Venous Blood (VB) Analysis
60 Days
Study Arms (1)
Reference therapy
EXPERIMENTAL* Baseline evaluation of subjects without acetazolamide administration * Follow up evaluation of subjects one hour after acetazolamide administration
Interventions
Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)
Eligibility Criteria
You may qualify if:
- Age ≥18 to 80 years
- TE-CSA
- Subjects are capable of giving informed consent
You may not qualify if:
- 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
- Liver failure
- Chronic hypercapnea
- Hyponatremia
- Hypokalemia
- Pregnancy
- Breastfeeding mothers
- Active drug/alcohol dependence or abuse history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Rapoport, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2016
First Posted
February 1, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
January 24, 2017
Record last verified: 2017-01