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Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02371473
Recruitment Status : Unknown
Verified May 2018 by Parisa Adimi, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : February 25, 2015
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Masih Daneshvari Hospital
Information provided by (Responsible Party):
Parisa Adimi, Shahid Beheshti University of Medical Sciences

Brief Summary:
Acetazolamide improves central sleep apnea related to opium consumption.

Condition or disease Intervention/treatment Phase
Central Sleep Apnea, Secondary Drug: Acetazolamide-placebo Drug: Placebo-acetazolamide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
Study Start Date : November 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 Name: 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 Name: Diamox. Drug and placebo are prepared in similar capsules.




Primary Outcome Measures :
  1. Changes in Central Apnea Index [ Time Frame: baseline and six days ]

Secondary Outcome Measures :
  1. Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24) [ Time Frame: baseline and six days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371473


Locations
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Iran, Islamic Republic of
Masih Daneshvari Hospital
Tehran, Iran, Islamic Republic of, 19569-44413
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Masih Daneshvari Hospital
Investigators
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Principal Investigator: Parisa Adimi, MD Shahid Beheshti University of Medical Sciences
Study Director: Moein Forughi, MD Shaheed Behesti Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Parisa Adimi, Associate Professor of Medicine, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02371473    
Other Study ID Numbers: CRD-93-04
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Parisa Adimi, Shahid Beheshti University of Medical Sciences:
Acetazolamide
Central Sleep Apnea
Opium Abuse
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs