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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sleep Apnea

Intervention / Treatment
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* Drug: Acetazolamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference therapy<br>Baseline evaluation of subjects without acetazolamide administration Follow up evaluation of subjects one hour after acetazolamide administration | Drug: Acetazolamide<br>* Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)<br>* Other names: Diamox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time 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 acetazolamide |  | 15 Minutes | 
| Measurement of Arterial Blood Gas (ABG) |  | 60 Days | 
| Measurement of Venous Blood (VB) Analysis |  | 60 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetazolamide, Treatment Emergent Sleep Disordered Breathing, Sleep Apnea