Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

NCT ID: NCT02371473

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-12-31

Brief Summary

Acetazolamide improves central sleep apnea related to opium consumption.

Detailed 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.

Conditions

Central Sleep Apnea, Secondary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

#1 (Acetazolamide-placebo)

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.

Group Type: EXPERIMENTAL

Acetazolamide-placebo

Intervention Type: DRUG

The patients in this arm are given Acetazolamide mg for six days and after 2 weeks washout they are given placebo for six days.

#2 (Placebo-acetazolamide)

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.

Group Type: EXPERIMENTAL

Placebo-acetazolamide

Intervention Type: DRUG

The patients in this arm are given placebo for six days and after 2 weeks washout they are given Acetazolamide for six days.

Interventions

Acetazolamide-placebo

The patients in this arm are given Acetazolamide mg for six days and after 2 weeks washout they are given placebo for six days.

Intervention Type: DRUG

Placebo-acetazolamide

The patients in this arm are given placebo for six days and after 2 weeks washout they are given Acetazolamide for six days.

Intervention Type: DRUG

Other Intervention Names

Diamox. Drug and placebo are prepared in similar capsules.; Diamox. Drug and placebo are prepared in similar capsules.

Eligibility Criteria

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

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

Sponsors

Masih Daneshvari Hospital

OTHER

Sponsor Role: collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Parisa Adimi

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parisa Adimi, MD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Moein Forughi, MD

Role: STUDY_DIRECTOR

Shaheed Behesti Medical University

Locations

Masih Daneshvari Hospital

Tehran, , Iran

Countries

Iran

References

Naghan PA, Raeisi K, Khoundabi B, Foroughi M, Malekmohammad M, Mohebbi M, Bagheri A, Fahimi F. The effect of acetazolamide on the improvement of central apnea caused by abusing opioid drugs in the clinical trial. Sleep Breath. 2020 Dec;24(4):1417-1425. doi: 10.1007/s11325-019-01968-3. Epub 2019 Dec 5.

Reference Type: DERIVED

PMID: 31808012 (View on PubMed)

Other Identifiers

CRD-93-04

Identifier Type: -

Identifier Source: org_study_id