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

Not Applicable

Withdrawn

• Conditions: Sleep Apnea
• Interventions: Drug: Acetazolamide

• Registration Number: NCT02670096
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Primary Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reference therapy	Acetazolamide	* Baseline evaluation of subjects without acetazolamide administration * Follow up evaluation of subjects one hour after acetazolamide administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States