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

NCT ID: NCT02670096

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference therapy

• Baseline evaluation of subjects without acetazolamide administration
• Follow up evaluation of subjects one hour after acetazolamide administration

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: DRUG

Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)

Interventions

Acetazolamide

Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)

Intervention Type: DRUG

Other Intervention Names

Diamox

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rapoport, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00756

Identifier Type: -

Identifier Source: org_study_id