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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670096
Enrollment
0
Registered
2016-02-01
Start date
2016-01-31
Completion date
2017-03-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea

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.

Interventions

DRUGAcetazolamide

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography60 Days
Total lung capacity before and after acetazolamide administration60 Days

Secondary

MeasureTime frame
Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)20 Minutes
Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide15 Minutes
Measurement of Arterial Blood Gas (ABG)60 Days
Measurement of Venous Blood (VB) Analysis60 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026