Back to resultsA Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
Primary Purpose
Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetazolamide
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 to 80 years
- TE-CSA
- Subjects are capable of giving informed consent
Exclusion Criteria:
- 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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Reference therapy
Arm Description
Baseline evaluation of subjects without acetazolamide administration Follow up evaluation of subjects one hour after acetazolamide administration
Outcomes
Primary Outcome Measures
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
Total lung capacity before and after acetazolamide administration
Secondary Outcome Measures
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
Measurement of Arterial Blood Gas (ABG)
Measurement of Venous Blood (VB) Analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02670096
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference therapy
Arm Type
Experimental
Arm Description
Baseline evaluation of subjects without acetazolamide administration
Follow up evaluation of subjects one hour after acetazolamide administration
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)
Primary Outcome Measure Information:
Title
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
Time Frame
60 Days
Title
Total lung capacity before and after acetazolamide administration
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
Time Frame
20 Minutes
Title
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
Time Frame
15 Minutes
Title
Measurement of Arterial Blood Gas (ABG)
Time Frame
60 Days
Title
Measurement of Venous Blood (VB) Analysis
Time Frame
60 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 to 80 years
TE-CSA
Subjects are capable of giving informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rapoport, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
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