Clinical trial NCT02371473: Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
Official title: Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Central Sleep Apnea, Secondary
Keywords: Acetazolamide
Central Sleep Apnea
Opium Abuse
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Masih Daneshvari Hospital
First posted: 2015-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Central Apnea Index
timeFrame: baseline and six days
Secondary outcomes:
measure: Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)
timeFrame: baseline and six days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Masih Daneshvari Hospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Parisa Adimi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaheed Behesti Medical University
name: Moein Forughi, MD
role: STUDY_DIRECTOR
References:
citation: 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.