NCT02371473

Brief Summary

Acetazolamide improves central sleep apnea related to opium consumption.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

3.6 years

First QC Date

December 6, 2014

Last Update Submit

May 5, 2018

Conditions

Central Sleep Apnea, Secondary

Keywords

AcetazolamideCentral Sleep ApneaOpium Abuse

Outcome Measures

Primary Outcomes (1)

  • Changes in Central Apnea Index

    baseline and six days

Secondary Outcomes (1)

  • Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)

    baseline and six days

Study Arms (2)

#1 (Acetazolamide-placebo)

EXPERIMENTAL

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

#2 (Placebo-acetazolamide)

EXPERIMENTAL

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

Interventions

Acetazolamide-placeboDRUG

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

Also known as: Diamox. Drug and placebo are prepared in similar capsules.
#1 (Acetazolamide-placebo)
Placebo-acetazolamideDRUG

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

Also known as: Diamox. Drug and placebo are prepared in similar capsules.
#2 (Placebo-acetazolamide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masih Daneshvari Hospital

Tehran, 19569-44413, Iran

Location

Related Publications (1)

  • 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.

    PMID: 31808012DERIVED

MeSH Terms

Conditions

Sleep Apnea, CentralOpium Dependence

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOpioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Parisa Adimi, MD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Moein Forughi, MD

    Shaheed Behesti Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 6, 2014

First Posted

February 25, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

IR(1)