1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effect of timing of administration of the drugs atomoxetine and trazodone in divided doses on the number of apneic episodes and sleep indexes in obstructive sleep apnea patients

Protocol summary

Study aim
Evaluating the effect of atomoxetine and trazodone on the number of apnea episodes and sleep indices in patients with obstructive sleep apnea in order to propose the optimal pharmacological treatment for obstructive sleep apnea
Design
A phase 3 randomized double-blind crossover clinical trial on 18 patients.
Settings and conduct
A sample size of 18 patients will be selected from the sleep clinic of Imam Khomeini Hospital and divided into placebo and intervention groups. The intervention group will receive 80 mg of atomoxetine at 6 PM and 50 mg of trazodone before sleep prior to undergoing polysomnography. The placebo group will take a placebo once at 6 PM and once before sleep. Then, they will be monitored overnight using polysomnography to assess the different stages of sleep and their respiratory status during sleep. One week later, the participants in the intervention and placebo groups will switch, and the study will be repeated.
Participants/Inclusion and exclusion criteria
Patients aged 21 - 65 with a diagnosis of obstructive sleep apnea in their medical records with an AHI of 20 from their latest polysomnography report, without a past medical history otherwise except for controlled hypertension, hyperlipidemia and diabetes mellitus, who are either noncompliant for the standard CPAP/BiPAP treatment and who are either not candidates for surgical treatment or are unwilling to receive surgical treatment.
Intervention groups
One group will receive two placebo atomoxetine tablets at 6 PM plus one placebo trazodone tablet 30 minutes before sleep on the first night, and the other group will receive two 40 mg atomoxetine tablets at 6 PM plus one 50 mg trazodone tablet 30 minutes before sleep.
Main outcome variables
Apnea-Hypopnea Index; Apnea Index; Hypopnea Index; Total Sleep Time; Daytime Sleepiness after the Study Night; Minimum Blood Oxygen Saturation; Average Blood Oxygen Saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240706062343N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: prospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Parsa Mirzayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2053
Email address
p-mirzayi@student.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of timing of administration of the drugs atomoxetine and trazodone in divided doses on the number of apneic episodes and sleep indexes in obstructive sleep apnea patients
Public title
Εvaluating the timing of administration of atomoxetine and trazodone on obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of obstructive sleep apnea in medical records with AHI=20 in latest polysomnography (if performed) Patients who are not candidates for or aren't compliant with standard obstructive sleep apnea treatments
Exclusion criteria:
Presence of other diseases (except for controlled hypertension, hyperlipidemia, diabetes) Usage of any drug that interferes with respiratory physiology, sleep/wake and muscles, including methocarbamol, tramadol, TCAs, SSRIs, SNRIs, respiratory stimulants of depressants, hypnotics, central nervous system stimulants, central sleep apnea, etc Claustrophobia Hypersensitivity to lidocaine, atomoxetine or trazodone Presence of underlying cardiac disease including arrhythmia Usage of psychiatric drugs (including atomoxetine) or any drug that is required for medical treatment and cannot be skipped on the night of the study In females: pregnancy History of seizure, panic disorder, hyperventilation syndrome, attention deficient hyperactivity disorder, autism spectrum disorder
Age
From 21 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 18
More than 1 sample in each individual
Number of samples in each individual: 2
One week after the initial night of the study, patients in the study group and the placebo group will be crossed over and studied again.
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomized by a third party using block randomization with blocks of 4, 6, and 8, and will be evenly assigned to two groups. The first group will receive the intervention in the first week and the placebo in the second week, while the second group will receive the placebo in the first week and the intervention in the second week.
Blinding (investigator's opinion)
Double blinded
Blinding description
n this double-blind study, the participants, the primary investigator (who is also the data collector), and the medical staff responsible for patient care during the study night and administering the medications will all be kept blind to the groups assigned to the patients.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Qarib Street, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.153

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
Number of apnea episodes
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

2

Description
Apnea-Hypopnea Index
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

Secondary outcomes

1

Description
Apnea Index
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

2

Description
Hypopnea Index
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

3

Description
Minimum arterial oxygen
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

4

Description
Mean arterial oxygen
Timepoint
Two nights one week apart
Method of measurement
Polysomnography

Intervention groups

1

Description
Intervention group: Two 40 milligram atomoxetine tablets at 6 pm, plus one 50 milligram trazodone tablet 30 minutes before bed
Category
Treatment - Drugs

2

Description
Control group: Two placebo tablets resembling atomoxetine at 6 pm plus one placebo tablet resembling trazodone 30 minutes before bed
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex Sleep Clinic
Full name of responsible person
Parsa Mirzayi
Street address
Qarib Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2053
Email
p-Mirzayi@student.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Sari
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@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
Parsa Mirzayi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2053
Email
p-Mirzayi@student.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Amirifard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Qarib street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1411419733141
Phone
+98 21 6119 2053
Email
Dr.amirifard@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Mirzayi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2053
Email
p-Mirzayi@student.tums.ac.ir

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...