Effects of a digital cognitive-behavior therapy for comorbid insomnia (CBT-I) for insomnia and obstructive sleep apnea (COMISA)

Effects of a digital cognitive-behavior therapy for comorbid insomnia (CBT-I) for insomnia and obstructive sleep apnea (COMISA) - ONSET_OSA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026096

Enrollment

105

Registered

2021-08-17

Start date

2021-11-03

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51.0 G47.3

Interventions

Group 1: Intervention group: Short medical consultation, handing out of sleep hygiene rules + continuous positive airway pressure therapy (CPAP therapy) + digital cognitive-behavior psychotherapy for

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Comorbid insomnia (F51.0) + sleep apnea (G47.3)

Exclusion criteria

Exclusion criteria: Excessive use of alcohol and drugs; suicidality; schizophrenia/acute psychosis; epilepsy

Design outcomes

Primary

Measure	Time frame
- insomnie: ISI Insomnia Severity Index (pre, post, follow-up 6 mon) - Apnoen: AHI Apnoe Hypopnoe Index (pre, post)	—

Secondary

Measure	Time frame
- adherence to CPAP therapy: nightly mask-wearing (hours/night; post, follow-up 6 mon, respectively) - unwanted other effects of CPAP therapy: SECI Side-effects to CPAP treatment (pre, post, follow-up 6 mon, respectively) - dysfunctional beliefs about sleep: DBAS-16 dysfunctional beliefs and attitudes about sleep (pre, post, follow-up 6 mon, respectively) - fatigue: FSS Fatigue Severity Index (pre, post, follow-up 6 mon, respectively) - sleepiness: ESS Epworth Sleepiness Scale (pre, post, follow-up 6 mon, respectively) - depression: CES-D Center for Epidemiologic Studies Depression Scale, short version (pre, post, follow-up 6 mon, respectively) - anxiety: STAI-T State-Trait Anxiety Inventory (pre, post, follow-up 6 mon, respectively) - arousal: PSAS Pre-sleep arousal scale (pre, post, follow-up 6 mon, respectively) - quality of life: WHOQOL_BREF WHO Quality of Life Questionnaire; WHO-5 WHO-5-Wohlbefindens-Index; Basic Psychological Need Satisfaction and Frustration Scale BPNSFS; SCI Stress and Coping Inventory (prä, post, Follow-Up 6 Mon) - dreaming: MADRE Mannheim Dream Questionnaire; CAN Cognitive Appraisal of Nightmares (pre, post, follow-up 6 mon, respectively)	—

Measure

Time frame

- adherence to CPAP therapy: nightly mask-wearing (hours/night; post, follow-up 6 mon, respectively) - unwanted other effects of CPAP therapy: SECI Side-effects to CPAP treatment (pre, post, follow-up 6 mon, respectively) - dysfunctional beliefs about sleep: DBAS-16 dysfunctional beliefs and attitudes about sleep (pre, post, follow-up 6 mon, respectively) - fatigue: FSS Fatigue Severity Index (pre, post, follow-up 6 mon, respectively) - sleepiness: ESS Epworth Sleepiness Scale (pre, post, follow-up 6 mon, respectively) - depression: CES-D Center for Epidemiologic Studies Depression Scale, short version (pre, post, follow-up 6 mon, respectively) - anxiety: STAI-T State-Trait Anxiety Inventory (pre, post, follow-up 6 mon, respectively) - arousal: PSAS Pre-sleep arousal scale (pre, post, follow-up 6 mon, respectively) - quality of life: WHOQOL_BREF WHO Quality of Life Questionnaire; WHO-5 WHO-5-Wohlbefindens-Index; Basic Psychological Need Satisfaction and Frustration Scale BPNSFS; SCI Stress and Coping Inventory (prä, post, Follow-Up 6 Mon) - dreaming: MADRE Mannheim Dream Questionnaire; CAN Cognitive Appraisal of Nightmares (pre, post, follow-up 6 mon, respectively)

—

Countries

Germany

Contacts

Public ContactAnnika Gieselmann

Heinrich-Heine-Universität Düsseldorf Institut für Experimentelle Psychologie Abteilung Klinische Psychologie

Annika.Gieselmann@hhu.de+49 211 81-10584

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026