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Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02371473
Enrollment
12
Registered
2015-02-25
Start date
2014-11-30
Completion date
2018-12-31
Last updated
2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea, Secondary

Keywords

Acetazolamide, Central Sleep Apnea, Opium Abuse

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.

Interventions

DRUGAcetazolamide-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.

DRUGPlacebo-acetazolamide

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

Sponsors

Masih Daneshvari Hospital
CollaboratorOTHER
Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in Central Apnea Indexbaseline and six days

Secondary

MeasureTime frame
Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)baseline and six days

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026