Evaluation of Effectiveness OF CBT-I (Cognitive Behavioral Therapy for Insomnia) on PAP adherence in COMISA (Co-Morbid Insomnia and Sleep Apnea) patients
Evaluation of Effectiveness OF CBT-I (Cognitive Behavioral Therapy for Insomnia) on PAP adherence in COMISA (Co-Morbid Insomnia and Sleep Apnea) patients
Design
In this study, patients suffering from Obstructive Sleep Apnea (OSA) and Insomnia, collectively referred to as COMISA, are divided into two groups: TAU (Treatment As Usual) and CBTI (Cognitive Behavioral Therapy for Insomnia). The usage of CPAP and the patients’ sleep status are evaluated using a sleep log and questionnaires (ESS, BECK, ISI, PSQI) at intervals of 1 week, 3 months, and 6 months post-intervention.
Settings and conduct
This randomized clinical trial at Imam Khomeini and Baharloo hospitals involves patients with OSA and Insomnia. Participants are randomly assigned to either the TAU or CBTI group. CPAP usage and sleep status are evaluated using a sleep log and questionnaires at specified intervals post-intervention. Both the researcher and therapist are blinded, with randomization done using a random number table and results kept in sealed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 18-70
Based on polysomnography findings, the individual experiences at least 15 or more episodes of apnea or hypopnea per hour of sleep.
Physician-confirmed OSA
CPAP therapy recommended and desired
Insomnia diagnosis by a psychologist
Exclusion Criteria:
CPAP use in past 4 months
Significant perceptual or behavioral disorders
Remote residence
Seizures
Night shift work
Intervention groups
The intervention group receives Cognitive Behavioral Therapy for Insomnia (CBTI) in four 45-minute sessions.
Main outcome variables
Insomnia Severity
Sleepiness
Stress and Anxiety
Sleep Patterns
CPAP Adherence
Beck Depression Inventory
Pittsburgh Sleep Quality Index
General information
Reason for update
Acronym
CBTI, CPAP, COMISA (Insomnia, OSA)
IRCT registration information
IRCT registration number:IRCT20190620043954N3
Registration date:2024-10-29, 1403/08/08
Registration timing:registered_while_recruiting
Last update:2024-10-29, 1403/08/08
Update count:0
Registration date
2024-10-29, 1403/08/08
Registrant information
Name
Khosroo sadeghniiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5546 0184
Email address
sadeghniiat@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness OF CBT-I (Cognitive Behavioral Therapy for Insomnia) on PAP adherence in COMISA (Co-Morbid Insomnia and Sleep Apnea) patients
Public title
The effectiveness of CBTI on PAP adherence in COMISA patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 – 70 years
AHI ≥ 15 events/hour of sleep on a full night PSG recording
sleep physician-confirmed OSA
recommendation for CPAP therapy and participant desire to try CPAP
a diagnosis of insomnia established by a psychologist
Exclusion criteria:
Another sleep disorder or medical disorder which required immediate treatment.
CPAP use within past 4 months
significant memory disorder, perceptual or behavioral disorder (Schizophrenia or bipolar disorders, concurrent psychotherapeutic interventions, suicidal tendencies, Drug or psychedelic abuse, Dementia)
place of residence significantly remote to preclude follow-up clinic visits
current participation in another research study
Seizure
Working at night shift
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block randomization, where an equal number of participants are assigned to the intervention and control groups at consecutive but equal time intervals. Each block size is 31 participants. For example, one type of treatment (usual care) is given to the first block, and another type (cognitive-behavioral therapy for insomnia) is given to the second block. This block randomization method ensures balance in the number of participants in each group. In this single-blinded study, the physician-investigator who assigns participants to the treatment groups is not informed about which treatment each participant receives, ensuring that the allocation process is unbiased.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blinded study, the physician-investigator who assigns participants to the treatment groups is unaware of the type of treatment each participant receives, ensuring that the allocation process remains unbiased.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committies of Imam Khomeini Hospital Complex-Tehran University of Medical Sciences
Street address
The Sleep Clinics at Imam Khomeini Hospital Complex & Baharloo Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.118
Health conditions studied
1
Description of health condition studied
The health condition studied in this clinical trial involves patients with both insomnia and sleep apnea (COMISA). These patients are randomly assigned to either a Cognitive Behavioral Therapy for Insomnia (CBT-I) group or a Treatment As Usual (TAU) group. The CBT-I group receives six weeks of therapy, including four 45-minute weekly sessions focused on insomnia management. Follow-up assessments occur at 1 week, 3 months, and 6 months post-intervention. In contrast, the TAU group follows standard CPAP procedures without additional follow-up or intervention between baseline and 6 weeks.
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
The primary outcome of average CPAP use duration can be assessed using specific adherence criteria. Commonly, CPAP adherence is defined by the following criteria:Minimum Usage Time: Patients should use the CPAP machine for at least 4 hours per night.Frequency of Use: This minimum usage should occur on at least 5 nights per week12.Objective Measurement: The CPAP device itself records the usage data, providing an objective measure of adherence3.These criteria help ensure that the data collected on CPAP use is consistent and reliable, allowing for an accurate evaluation of the effectiveness of CBT-I on PAP adherence in patients with COMISA.
Timepoint
The primary outcome assessments will be conducted at intervals of 1 week, 3 months, and 6 months post-intervention.
Method of measurement
Commonly, CPAP adherence is defined by the following criteria:Minimum Usage Time: Patients should use the CPAP machine for at least 4 hours per night.Frequency of Use: This minimum usage should occur on at least 5 nights per week12.Objective Measurement: The CPAP device itself records the usage data, providing an objective measure of adherence.These criteria help ensure that the data collected on CPAP use is consistent and reliable, allowing for an accurate evaluation of the effectiveness of CBT-I on PAP adherence in patients with COMISA.
Secondary outcomes
1
Description
Secondary outcomes are investigated by following questionnaires: Insomnia Severity: Assessed using the Insomnia Severity Index (ISI). Sleepiness: Evaluated with the Epworth Sleepiness Scale (ESS). Sleep Patterns: Tracked over one week using a 7-day Sleep Log. Depression: Assessed with the Beck Depression Inventory (BECK). Sleep Quality: Evaluated using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint
The secondary outcome assessments will be conducted at intervals of 1 week, 3 months, and 6 months post-intervention.
Method of measurement
According to the latest studies, the scores of the questionnaires are considered as follows: 1. Epworth Sleepiness Scale (ESS): Score Range: 0 to 24. In our study ESS less than 10 is considered. 2. Beck Depression Inventory (BDI):Score Range: 0 to 63. In our study BDI less than 10 is considered. 3. Insomnia Severity Index (ISI): Score Range: 0 to 28. In our study ISI less than 10 is considered. 4. Pittsburgh Sleep Quality Index (PSQI): Score Range: 0 to 21. In our study PSQI less than 5 is considered. 5. Sleep Diary: Parameters: Bedtime, wake time, number of awakenings, total sleep time, sleep efficiency, and subjective sleep quality. Interpretation: Trends and patterns over time are analyzed rather than a single score.These scales will help us quantify the severity of symptoms and the effectiveness of our interventions, providing a clear picture of the secondary outcomes related to sleep and mental health in our study.
Intervention groups
1
Description
Intervention Group: Cognitive Behavioral Therapy for Insomnia (CBT-I) will be conducted in four 45-minute sessions for participants who meet the study inclusion criteria. The calculated sample size for each group is 31 participants, but to account for potential dropouts, the study will start with 40 participants in each group.The content of the CBT-I intervention sessions, based on previous studies, will include:Session One: Sleep Education and Bed Restriction Therapy (BRT)Session Two: Misperception of Sleep and PSG FeedbackSession Three: Hyperarousal and Anxiety in InsomniaSession Four: Intervention Review and Relapse PreventionThe content of the CBT-I sessions and the therapist will be consistent across individuals and groups. The therapist or fellowship will conduct an introductory session with the patients, providing an organized manual, session checklist, and special session slides to ensure participation and engagement in the therapy. Participants will also receive a booklet to inform them about the intervention and the type of treatment.
Category
Treatment - Other
2
Description
Control Group: (TAU) Participants in the “Treatment as Usual” (TAU) group do not have any follow-up appointments between the 6-week follow-up session and the initial session. However, all of them will have PAP titration, CPAP usage, and appointments between 6 weeks and 6 months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sleep Clinic in Imam Khomein Hospital Complex-Tehran University of Medical Sciences
Full name of responsible person
Khosro Sadeghniiat
Street address
North Gate Route: Tehran – East of Chamran Expressway – Bagherkhan East Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 603 9896
Email
sadeghniiat@yahoo.com
Web page address
https://www.iransleep.com/pe/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khosro Sadeghniiat
Street address
East Door: End of Keshavarz Boulevard - Dr. Gharib Street
Sleep Clinic of Imam Khomeini Hospital- Tehran University of Medical Science
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
Dr. Anis Fard Mousavi
Position
Sleep Subspecialist
Latest degree
Specialist
Other areas of specialty/work
Pulmonologist
Street address
North Door: East Bagher Khan Street, East of Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 646 5878
Email
dranisfardmousavi@gmail.com
Web page address
https://drnafas.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Anis Fard Mousavi
Position
Sleep subspecialist
Latest degree
Specialist
Other areas of specialty/work
Pulmonologist
Street address
North Door of Hospital: East Bagher Khan Street, East of Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 646 5878
Email
dranisfardmousavi@gmail.com
Web page address
https://drnafas.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Sepahdoost
Position
Project Associate in the Behavioral-Cognitive Section
Latest degree
Master
Other areas of specialty/work
Cognitive-behavioral therapist
Street address
North Door: East Bagher Khan Street, East of Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 603 9896
Email
sepahdoost.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Title: Evaluation of the Effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Positive Airway Pressure (PAP) Adherence in Patients with Co-Morbid Insomnia and Sleep Apnea (COMISA).
Objective: To assess whether CBT-I can improve adherence to PAP therapy in patients with both insomnia and sleep apnea.
Participants: Individuals with co-morbid insomnia and sleep apnea recruited from Imam Khomeini and Baharloo hospitals.
Assessment Time Points: Evaluations are conducted at 1 week, 3 months, and 6 months post-intervention.
Outcome Measures: The study likely includes sleep quality questionnaires, CPAP adherence data, and other relevant factors.
When the data will become available and for how long
Approximately 1 year and half
To whom data/document is available
researcher & Research Deputy of University of Tehran
Under which criteria data/document could be used
Data and documents in the mentioned clinical trial can be used under several key criteria, including:
Informed Consent: Participants must provide informed consent, which includes agreeing to how their data will be used and shared.
Ethical Approval: The study must have ethical approval from the Ethics Committee of Tehran University of Medical Sciences to ensure that data usage complies with ethical standards.
Confidentiality and Privacy: Data must be anonymized to protect participant privacy, and any data sharing must comply with privacy laws and regulations.
Data Integrity: Data should be accurate, complete, and maintained in a way that ensures its integrity. Any changes to the data should be traceable and documented.
Regulatory Compliance: The use of data must comply with relevant regulatory requirements, such as those set by the FDA.
Purpose of Use: Data should be used for the purposes outlined in the study protocol, such as analyzing treatment effectiveness or safety.
These criteria help ensure that data is used responsibly and ethically throughout the clinical trial process.
From where data/document is obtainable
Sleep clinic of Imam Khomeini Hospital & Baharloo Hospital.
What processes are involved for a request to access data/document
We’re still in the process of making a decision.
Comments
We've aimed for clarity in presenting the key points. If anything remains unclear, please don't hesitate to ask for clarification.