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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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ClinicalTrials.gov Identifier: NCT02670096
Recruitment Status : Withdrawn
First Posted : February 1, 2016
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Acetazolamide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Reference therapy
  • Baseline evaluation of subjects without acetazolamide administration
  • Follow up evaluation of subjects one hour after acetazolamide administration
Drug: Acetazolamide
Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)
Other Name: Diamox




Primary Outcome Measures :
  1. Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography [ Time Frame: 60 Days ]
  2. Total lung capacity before and after acetazolamide administration [ Time Frame: 60 Days ]

Secondary Outcome Measures :
  1. Gas composition with and without acetazolamide using Resting Ventilation Study (RVS) [ Time Frame: 20 Minutes ]
  2. Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide [ Time Frame: 15 Minutes ]
  3. Measurement of Arterial Blood Gas (ABG) [ Time Frame: 60 Days ]
  4. Measurement of Venous Blood (VB) Analysis [ Time Frame: 60 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670096


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David Rapoport, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02670096    
Other Study ID Numbers: 15-00756
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by NYU Langone Health:
acetazolamide
Treatment Emergent Sleep Disordered Breathing
Sleep Apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiratory Aspiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs