Protocol summary
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Study aim
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Defining the effects of combination therapy with atomoxetine and trazodone on the number of respiratory arrests and on apnea-hypopnea indices in patients with obstructive sleep apnea
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Design
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Cross-over clinical trial, double-blind, randomized, phase 2-3, on 18 patients
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Settings and conduct
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Imam Khomeini Hospital Complex's Sleep Disorders Center
In order to randomize, the random block method has been used.
Patients are randomly divided into two groups, A and B, with equal numbers. In the first session, group A receives the placebo half an hour before bedtime and group B receives the study drug half an hour before bedtime, and in the second session, group A receives the study drug half an hour before bedtime and group B receives the placebo half an hour before bedtime.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : medical history of obstructive sleep apnea with an 15<AHI on the last polysomnogram, age between 18 and 65, incompatibility with CPAP or BiPAP treatment, not being a candidate for surgery or not wanting surgery, and not being able to use CPAP or BiPAP.
Exclusion criteria: Existence of any commodities (except controlled blood pressure, hyperlipidemia and diabetes), Existence of any underlying heart disease, pregnancy, sensitivity to the drugs used in the study, use of any drug that leads to changes in the physiology of respiration, sleep/wake and muscles, inability to sleep in a supine position
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Intervention groups
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Each patient will treated once with a combination of 80 mg of atomoxetine and 50 mg of trazodone and once with placebo.
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Main outcome variables
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Improve sleep quality and reduce sleep apnea and hypopnea attacks
General information
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Reason for update
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Registering the completion of Patient recruitment and completion of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220607055095N1
Registration date:
2022-06-26, 1401/04/05
Registration timing:
prospective
Last update:
2023-07-24, 1402/05/02
Update count:
3
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Registration date
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2022-06-26, 1401/04/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-06, 1401/04/15
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Expected recruitment end date
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2023-08-23, 1402/06/01
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Actual recruitment start date
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2022-07-06, 1401/04/15
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Actual recruitment end date
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2022-12-22, 1401/10/01
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Trial completion date
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2023-01-21, 1401/11/01
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Scientific title
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Evaluating the effects of the Atomoxetine and Trazodone combination on the number of apneas and apnea-hypopnea sleep index in obstructive sleep apnea patients referred to the sleep clinic of Imam Khomeini hospital.
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Public title
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ٍEffects of Atomoxetine and Trazodone combination in obstructive sleep apnea
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Definite diagnosis of obstructive sleep apnea in medical history with AHI>15 in polysomnography
lack of compliance treatment with CPAP or BIPAP
either the patient is unwilling to have surgery or they are not candidates for surgery in the opinion of the expert
Exclusion criteria:
commodities' existence (excluding controlled blood pressure, hyperlipidemia and diabetes)
any underlying cardiac disease, such as arrhythmia that is seen on the ECG
History of seizures, Panic disorder, Hyperventilation syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
Hypersensitivity to lidocaine, atomoxetine or trazodone, substances used in placebo
Taking any medication that leads to changes in the physiology of breathing, sleep / wake and muscles Taking any medication that leads to changes in the physiology of breathing, sleeping / waking and muscles
Inability to sleep in supine position
Pregnancy
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
18
Actual sample size reached:
18
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to randomize, the random block method has been used. In this method, blocks of 4, 6 and 8 are used.
Patients are randomly divided into two groups A and B with equal numbers. In the first session, group A receives the placebo half an hour before bedtime and group B receives the study drug half an hour before bedtime, and in the second session, group A receives the study drug half an hour before bedtime and group B receives placebo half an hour before bedtime.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patient does not know in which treatment group he is. The data analyzer does not know about the treatment performed.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-15, 1400/12/24
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1401.002
Health conditions studied
1
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Description of health condition studied
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obstructive sleep apnea
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ICD-10 code
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G47.33
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ICD-10 code description
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Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
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Description
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Apnea-hypopnea index
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Timepoint
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medication Night
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Method of measurement
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Polysomnography
Secondary outcomes
1
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Description
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safety
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Timepoint
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The morning after taking the drug
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Method of measurement
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asking the patient
Intervention groups
1
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Description
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Intervention group: Patients are treated with 80 mg of atomoxetine (Mofid company) and 50 mg of trazodone (Razak company) once half an hour before the polysomnography test and then undergo polysomnography overnight.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients are treated with placebo once half an hour before the polysomnography test and then undergo polysomnography overnight.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable