F51.0
Conditions
Interventions
Group 1: placebo
Group 2: Patients in the intervention arm receive a medical device which emits frequencies in the evening which have a positive and appeasing effect on the patients and are intended t
Sponsors
HealthBalance AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Patients aged between 18-75 years • Patients with clinical diagnosis of insomnia • No clinical evidence for organic dyssomnia • Informed consent form signed by the patient
Exclusion criteria
Exclusion criteria: • Obstructive or central sleep apnoea or dyssomnia • Restless-Leg-Syndrom or clinically relevant PLMD (Periodic Leg Movement Disorder) • Drug, sleeping pills or alcohol abuse • Use of psychotropic drugs • Depression or other psychic disorders within the last 12 months • Heart failure; ejection fraction < 40% • Exacerbated COPD / bronchial asthma • Shiftwork or frequent changes of time zones (for example stewards, frequent business trips, etc.) • Not recovered from malignant diseases • Advanced systemic diseases (for example autoimmune diseases, chronic inflammatory diseases, etc) • Endocrinologic diseases (uncontrolled thyroid disorders, Cushing´s disease, hypophyseal diseases) • Pregnancy or no contraception in sexually active women • Lactation period • Dementia • Participation in another study • Persons in a dependent or working relationship to sponsor or investigator • Detained persons or minors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Successful treatment of insomnia after 8 weeks with Pittsburgh sleep quality index (PSQI) improved by 3 points or normalization of the PSQI (< 5 points) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary target is the evidence of safety with disclosure of relevant side effects of the product (Serious adverse device effect – SADE). Another second target is the evidence of mean contentment of at least 7 points (7/10 PSQI points). | — |
Countries
Germany
Contacts
Public ContactTanja Kottmann
CRO Dr. med. Tanja Kottmann
Outcome results
None listed