Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Central Sleep Apnea, Secondary Clinical Trial

Official title:

Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02371473
• Other study ID #: CRD-93-04
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acetazolamide improves central sleep apnea related to opium consumption.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea, Secondary
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Masih Daneshvari Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences	Masih Daneshvari Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Central Apnea Index		baseline and six days
Secondary	Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)		baseline and six days