pilot study of medium term effects of Trazodone and Atomoxetine combination on the number of apnea and apnea-hypopnea sleep index in obstructive sleep apnea patients
Defining the medium term 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
Design
non randomised, non blinded clinical trial without control group on 18 patients
Settings and conduct
After recruitment , patients referred to the sleep clinic of Imam Khomeini Hospital are treated with the combination of atomoxetine and trazodone for one month, and after that they undergo polysomnography.
Participants/Inclusion and exclusion criteria
Inclusion criteria : medical history of obstructive sleep apnea with an AHI of 15 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
Intervention groups
All included patients are treated for one month with the combination of atomoxetine 40 mg and Trazodone 50 mg.
Main outcome variables
Improve sleep quality and reduce sleep apnea and hypopnea attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220607055095N2
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Mojtaba Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 3770
Email address
mojtaba.shahba94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
pilot study of medium term effects of Trazodone and Atomoxetine combination on the number of apnea and apnea-hypopnea sleep index in obstructive sleep apnea patients
Public title
study of medium term effects of Trazodone and Atomoxetine combination in obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of obstructive sleep apnea 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)
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
any underlying cardiac disease, such as arrhythmia
Inability to sleep in supine position
Hypersensitivity to lidocaine, atomoxetine or trazodone
Pregnancy
History of seizures, Panic disorder, Hyperventilation syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
any hepatic disease or failure
Age
From 21 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of medical sciences
Street address
Imam Khomeini Hospital Complex ,Dr. Gharib Street ,Keshavarz Boulevard ,Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.111
Health conditions studied
1
Description of health condition studied
obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
Apnea-hypopnea index
Timepoint
after on month medication consumption
Method of measurement
Polysomnography
Secondary outcomes
1
Description
minimum O2 saturation
Timepoint
once
Method of measurement
pulse oxymetry
Intervention groups
1
Description
Intervention group: All patients are treated with a combination of atomoxetine and trazodone for one month, and then undergo polysomnography.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Arezu Najafi
Street address
Imam Khomeini Hospital Complex ,Dr. Gharib Street ,Keshavarz Boulevard ,Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 8899
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
اکبر فتوحی
Street address
Keshavarz Blvd, Ghods Avene, Ghods building
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezu Najafi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Occupational Medicine
Street address
Tehran, Railway Square, Behadari St., Baharlo Hospital, Occupational Sleep Disorders Research Center
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5546 0184
Email
najafeeaz.inbox@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezu Najafi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Occupational Medicine
Street address
Tehran, Railway Square, Behadari St., Baharlo Hospital, Occupational Sleep Disorders Research Center
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5546 0184
Email
najafeeaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Shahbazi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital Complex ,Dr. Gharib Street ,Keshavarz Boulevard ,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6694 8899
Email
mojtaba.shahba94@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available