Obstructive Sleep Apnea (OSA). Sleep apnea
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Patients diagnosed with obstructive sleep apnea who receive treatment with Continuous Positive Airway Pressure (CPAP). The duration of CPAP usag
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnosis of OSA (Apnea-Hypopnea Index = 5) confirmed by polysomnography (PSG) Age between 18 and 80 years CPAP usage for at least 1 month prior to study enrollment BMI less than 40
Exclusion criteria
Exclusion criteria: Other sleep disorders (e.g., central sleep apnea or narcolepsy) Severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) Use of medications influencing sleep architecture (e.g., benzodiazepines or sedatives) BMI greater than 40 Inability to tolerate or use the CPAP device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression score assessed using the PHQ-9 questionnaire at baseline, 3 months, and 6 months after CPAP therapy. This psychological outcome evaluates the impact of treatment on mood. Timepoint: The primary outcome variable will be measured at the following timepoints:Before the initiation of CPAP therapy (baseline)3 months after the start of therapy6 months after the start of therapy. Method of measurement: Depression severity will be measured using the nine-item Patient Health Questionnaire. This self-administered tool assesses the presence and severity of depressive symptoms.;Daytime sleepiness score measured using the Epworth Sleepiness Scale at baseline, 3 months, and 6 months after CPAP initiation. This variable reflects improvements in core symptoms of obstructive sleep apnea. Timepoint: The primary outcome variable will be measured at the following timepoints:Before the initiation of CPAP therapy (baseline)3 months after the start of therapy6 months after the start of therapy. Method of measurement: Daytime sleepiness will be assessed using the Epworth Sleepiness Scale questionnaire. This is a standardized self-report questionnaire consisting of 8 items, completed by the participant.;Mean nightly CPAP usage duration (in hours), as recorded by the CPAP device, over the 6-month follow-up period. This variable reflects adherence to therapy and serves as the basis for analyzing its association with clinical and psychological outcomes. Timepoint: The primary outcome variable will be measured at the following timepoints:Before the initiation of CPAP therapy (baseline)3 months after the start of therapy6 months after the start of therapy. Method of measurement: Nightly usage duration of the Continuous Positive Airway Pressure device will be measured using data automatically recorded by the internal memory of the device. These usage data will be extracted and reviewed by the research team using the manufacturer's software, under the supervision of a physician. disturb | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction with Continuous Positive Airway Pressure therapy will be measured using a standardized questionnaire assessing comfort, perceived effectiveness, and willingness to continue the treatment. Timepoint: At the end of week 4 (1 month after initiation of CPAP therapy) and at the end of week 24 (6 months after initiation of therapy). Method of measurement: Patient satisfaction will be assessed using a standardized questionnaire for satisfaction with Continuous Positive Airway Pressure therapy, which includes items on comfort, perceived effectiveness, and willingness to continue treatment. The questionnaire will be self-administered.;Adverse effects associated with Continuous Positive Airway Pressure usage, such as nasal dryness, eye irritation, facial discomfort, and sleep disturbance, will be assessed using a self-report adverse events log completed by participants. Timepoint: At week 2, week 4, and week 24 after initiation of Continuous Positive Airway Pressure therapy. Method of measurement: Adverse effects will be evaluated using a self-report adverse events log specifically designed for patients with obstructive sleep apnea undergoing Continuous Positive Airway Pressure therapy. Participants will complete the log at designated timepoints.;Body weight and Body Mass Index will be measured at defined timepoints using a digital scale and a measuring tape for height. Measurements will be taken in the morning while fasting and wearing light clothing. Timepoint: At baseline (before starting treatment), at week 4, and at week 24 after initiation of therapy. Method of measurement: Body weight will be measured using a calibrated digital scale, and height will be measured using a standard metal measuring tape. Body Mass Index will be calculated by dividing weight in kilograms by the square of height in meters. Measurements will be conducted while fasting and wearing light clothing.;Family cohesion and perceived social support will be assessed using the Famil | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactzahra saedi
Mashhad University of Medical Sciences
Outcome results
None listed