Efficacy of SLEEPYwave in Treatment of Patients with Insomnia
- Conditions
- F51.0Nonorganic insomnia
- Registration Number
- DRKS00009702
- Lead Sponsor
- HealthBalance AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 134
•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
•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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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 Outcome Measures
Name Time Method 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).