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

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02670096

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Drug: Acetazolamide	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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