Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Central Sleep Apnea, Secondary

Treatments: Drug: Placebo-acetazolamide; Drug: Acetazolamide-placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02371473

CRD-93-04

Details and patient eligibility

About

Acetazolamide improves central sleep apnea related to opium consumption.

Full description

This is a double-blind, placebo-controlled, cross-over designed study to evaluate the effect of acetazolamide on central apneas in opium-user patients.

We are going to invite 12 eligible patients to enter our study. this sample will be obtained from the referral patients to Masih Daneshvari hospital sleep Lab. Eligible patients will undergo a full night polysomnography (PSG) to have a new measure of apnea indexes as baseline. Epwoth Sleepiness Scale Questionnaire (ESS) will be filled by the patient the night of the study.also an arterial blood sample will be obtained at the morning of each study. if the patient have more than 5 central apneas in each hour he/she will be scheduled to randomly receive a box containing 6 capsules to use one hour before bedtime at coming nights. The prescriber physician who will also score the tests and the patients are unaware either these capsules are acetazolamide 250mg or placebo. at 6th night we will perform PSG together with ESS questionnaire and arterial blood gas (ABG). after 2 weeks washout the patient receive another box containing 6 capsules with similar appearance to previous ones. If the patient receives acetazolamide in the first six nights, he/she will receive placebo in the second phase of the study and if the patient receives placebo in the first phase, he/she will receive acetazolamide in the second phase.

after the second 6 days, the third PSG will be performed plus ESS measurement and morning ABG sampling. Coded polysomnograms will be scored blindly.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Opium or opioid use for at least two months in a daily manner
• Presence of five or more central sleep apnea per hour in a full-night recorded PSG

Exclusion criteria

• Congestive heart failure
• living in high altitude
• Chronic Obstructive Pulmonary Disease (COPD)
• Carbon dioxide partial pressure (pCO2) elevation due to other respiratory diseases
• Body Mass Index (BMI) > 32
• Obesity Hypoventilation Syndrome
• Severe renal or liver disorders
• Using Benzodiazepine
• Using Theophylline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

#1 (Acetazolamide-placebo)

Experimental group

Description:

The arm #1 consists of 6 eligible patients who receive Acetazolamide 250mg once daily an hour before sleep for first six nights and after two weeks washout they receive placebo for six nights in the same order. After each six-day period they undergo polysomnography.

Treatment:

Drug: Acetazolamide-placebo

#2 (Placebo-acetazolamide)

Experimental group

Description:

The arm #2 consists of 6 eligible patients who receive placebo once daily an hour before sleep for first six nights and after two weeks washout they receive acetazolamide 250mg for six nights in the same order. After each six-day period they undergo polysomnography.

Treatment:

Drug: Placebo-acetazolamide