Sleep quality and quality of life with long-term drug therapy for moderate to severe insomnia

Recruiting

Conditions: F51.0
Nonorganic insomnia

Registration Number: DRKS00033175

Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 105

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity measured via the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Name	Time	Method
- Subjective sleep time and sleep quality: sleep diary (sleep onset latency SL, waking time after falling asleep WASO, sleep duration TST, sleep efficiency SE)<br>- Pittsburgh Sleep Quality Index (PSQI)<br>- 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)<br>- Therapy-relevant side effects<br>- Loss of efficacy and extent of medication optimization (incl. switching) over the course of one year<br>- Beck Depression Inventory (BDI-II)