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 standar
Conditions
Interventions
Intervention 1: 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 calculate
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Anis Fard Mousavi
Tehran University of Medical Sciences
Outcome results
None listed