F51.0
Conditions
Interventions
Group 1: Medication according to the graduated therapy scheme for insomnia:
Study participants will receive appropriate medication according to a graduated therapy scheme for insomnia after taking a
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Patients with chronic insomnia according to the ICSD-3 definition - Insomnia severity moderate to severe (ISI > 14) - Written consent of the patient after verbal and written information - no previous drug therapy for moderate to severe insomnia for at least 3 months
Exclusion criteria
Exclusion criteria: - Patients who have already received any type of therapy for moderate to severe insomnia without subjective and objective benefit - Patients with severe, life-limiting illnesses and symptoms that significantly impair sleep, independent of insomnia, such as malignant diseases, pain disorders, unstable or exacerbated illnesses, etc. - Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia severity measured via the Insomnia Severity Index (ISI) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subjective sleep time and sleep quality: sleep diary (sleep onset latency SL, waking time after falling asleep WASO, sleep duration TST, sleep efficiency SE) - Pittsburgh Sleep Quality Index (PSQI) - SF-36 score (general health perception, physical health, limited physical-related role function, physical pain, vitality, mental health, limited emotional-related role function, social functioning) - Therapy-relevant side effects - Loss of efficacy and extent of medication optimization (incl. switching) over the course of one year - Beck Depression Inventory (BDI-II) | — |
Countries
Germany
Contacts
Public ContactIngo Fietze
Charité-Universitätsmedizin Berlin
Outcome results
None listed