Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

May 5, 2018 updated by: Parisa Adimi, Shahid Beheshti University of Medical Sciences
Acetazolamide improves central sleep apnea related to opium consumption.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #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.
Drug: 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.
Other Names:
  • Diamox. Drug and placebo are prepared in similar capsules.
Experimental: #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.
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.
Other Names:
  • Diamox. Drug and placebo are prepared in similar capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Central Apnea Index
Time Frame: baseline and six days
baseline and six days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)
Time Frame: baseline and six days
baseline and six days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Masih Daneshvari Hospital

Investigators

  • Principal Investigator: Parisa Adimi, MD, Shahid Beheshti University of Medical Sciences
  • Study Director: Moein Forughi, MD, Shaheed Behesti Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 6, 2014

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 5, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-93-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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