ELAMUS – A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly
Phase 4
- Conditions
- sleep disorders in the eldery
- Registration Number
- DRKS00031886
- Lead Sponsor
- Karl und Veronica Carstens-Stiftung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
age = 70 with geriatric typical multimorbidity or age over 80 years
- PSQI score = 5
- sufficient hearing ability
- available declaration of consent
- sufficient language skills
Exclusion Criteria
- Cognitive impairment (MoCA score = 18).
- Blood clotting disorders or medications that limit blood clotting
- Acute mental and nervous system disorders
- Acute suicidal tendencies
- Serious illness (e.g., cancer)
- Skin diseases (e.g., psoriasis)
- Contact allergies (e.g. nickel, chrome, silicone)
- needle phobia
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sleep quality, assessed via Pittsburgh Sleep Quality Index (PSQI)
- Secondary Outcome Measures
Name Time Method Daytime Sleepiness (Essen Questionnaire Age and Sleepiness, EFAS), Depression (Geriatric Depression Scale, GDS-15), Health-Related Quality of Life (SF-12), Neurovegetative Activity (Heart Rate Variability Measure, HRV), ca. n= 3-5 interviews with patients