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

Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02670096
• Other study ID #: 15-00756
• Status: Withdrawn
• Phase: N/A
• First received: January 21, 2016
• Last updated: January 23, 2017
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Drug:
• Acetazolamide
Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography		60 Days
Primary	Total lung capacity before and after acetazolamide administration		60 Days
Secondary	Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)		20 Minutes
Secondary	Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide		15 Minutes
Secondary	Measurement of Arterial Blood Gas (ABG)		60 Days
Secondary	Measurement of Venous Blood (VB) Analysis		60 Days