Central Sleep Apnea, SecondaryPhase 4NCT02371473
Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
A Phase 4 study of Central Sleep Apnea, Secondary, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Acetazolamide improves central sleep apnea related to opium consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, Secondary
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- Nov 2014to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe renal or liver disorders
- Using Benzodiazepine
- Using Theophylline
Trial locations and contacts
1 site in 1 country.
About this study
Acetazolamide improves central sleep apnea related to opium consumption.
Read the 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.
- Conditions
- Central Sleep Apnea, Secondary
- Being tested
- Acetazolamide-placebo, Placebo-acetazolamide
- Keywords
- Acetazolamide, Central Sleep Apnea, Opium Abuse
- Medical subject headings
- Sleep Apnea, Central, Opium Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide-placeboDrug
Also called Diamox. Drug and placebo are prepared in similar capsules.
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-acetazolamideDrug
Also called Diamox. Drug and placebo are prepared in similar capsules.
The patients in this arm are given placebo for six days and after 2 weeks washout they are given Acetazolamide for six days.
| Study group | Role | What they receive |
|---|---|---|
| #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. Receives: 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. Receives: Drug: Placebo-acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Central Apnea Index
Measured: baseline and six days
Secondary outcomes (1)
Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)
Measured: baseline and six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Sleep Apnea, SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Masih Daneshvari Hospital
- Responsible party
- Principal investigator, Parisa Adimi, Shahid Beheshti University of Medical Sciences
- Investigators
- Parisa Adimi, MD, Principal investigator, Shahid Beheshti University of Medical SciencesMoein Forughi, MD, Study director, Shaheed Behesti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371473
- Sponsor's protocol ID
- CRD-93-04
- Status last verified
- May 2018
- First submitted
- 6 Dec 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31808012
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
- ClinicalTrials.gov ID
- NCT02371473
- Acronym / sponsor ID
- CRD-93-04
- Conditions
- Central Sleep Apnea, Secondary
- Keywords
- Acetazolamide, Central Sleep Apnea, Opium Abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Masih Daneshvari Hospital
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #1 (Acetazolamide-placebo) | Experimental | Drug: Acetazolamide-placeboThe 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. |
| #2 (Placebo-acetazolamide) | Experimental | Drug: Placebo-acetazolamideThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide-placeboAlso: Diamox. Drug and placebo are prepared in similar capsules.The patients in this arm are given Acetazolamide mg for six days and after 2 weeks washout they are given placebo for six days. | Drug | #1 (Acetazolamide-placebo) |
| Placebo-acetazolamideAlso: Diamox. Drug and placebo are prepared in similar capsules.The patients in this arm are given placebo for six days and after 2 weeks washout they are given Acetazolamide for six days. | Drug | #2 (Placebo-acetazolamide) |
Primary outcome
Changes in Central Apnea Index
Time frame: baseline and six days
1 secondary outcome
Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)
Time frame: baseline and six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 31808012Naghan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parisa Adimi, MD principal investigator
Shahid Beheshti University of Medical Sciences
Moein Forughi, MD study director
Shaheed Behesti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Central Sleep Apnea, Secondary, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Central Apnea Index (time frame: baseline and six days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.