A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing

January 23, 2017 updated by: NYU Langone Health
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Diamox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
Time Frame: 60 Days
60 Days
Total lung capacity before and after acetazolamide administration
Time Frame: 60 Days
60 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: David Rapoport, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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