Trial document




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  DRKS00009702

Trial Description

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Title

Efficacy of SLEEPYwave in Treatment of Patients with Insomnia

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Treatment with SLEEPYwave belongs to physical informational medicine, just like resonance coupling and bio-resonance, and is a therapy where varying frequencies are emitted. The thesis is that the oscillations have an effect on the body and harmonize signal processing in the human body. It is assumed that the effect results from positive impact of the oscillations on the nerve cells. Ultimately, the mode of action is still unclear so that the treatment is based on positive experience with bio-resonance or resonance coupling.

So far, resonance coupling has been used successfully with a precursor type, MIDIwave. SLEEPYwave emits oscillations just as MIDIwave during daytime, but has also been supplemented by oscillations in the evening which develop an appeasing oscillation section after the evening mode is switched on.

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Brief Summary in Scientific Language

The SLEEPYwave belongs to physical informational medicine, just like resonance coupling and bio-resonance, and is a therapy where varying frequencies are emitted. The thesis is that the oscillations have an effect on the body and harmonize signal processing in the human body. It is assumed that the effect results from positive impact of the oscillations on the nerve cells. Ultimately, the mode of action is still unclear so that the treatment is based on positive experience with bio-resonance or resonance coupling.

So far, resonance coupling has been used successfully with a precursor type, MIDIwave. SLEEPYwave emits oscillations just as MIDIwave during daytime, but has also been supplemented by oscillations in the evening which develop an appeasing oscillation section after the evening mode is switched on.

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Organizational Data

  •   DRKS00009702
  •   2015/11/20
  •   [---]*
  •   no
  •   Approved
  •   2015332, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   CIV-15-08-013797 
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Health Condition or Problem studied

  •   F51.0 -  Nonorganic insomnia
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Interventions/Observational Groups

  •   placebo
  •   Verum Group with bioresonance
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- Successful treatment of insomnia after 8 weeks with Pittsburgh sleep quality index (PSQI) improved by 3 points or normalization of the PSQI (< 5 points)

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Secondary Outcome

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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/11/25
  •   134
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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

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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

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Addresses

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    • HealthBalance AG
    • Sonnenhügelstraße 8
    • 9240  Uzwil
    • Switzerland
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    • CRO Dr. med. Tanja Kottmann
    • Ms.  Dr. med.  Tanja  Kottmann 
    • Beverstr. 64
    • 59077  Hamm
    • Germany
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    • CRO Dr. med. Tanja Kottmann
    • Ms.  Dr. med.  Tanja  Kottmann 
    • Beverstr. 64
    • 59077  Hamm
    • Germany
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Sources of Monetary or Material Support

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    • HealthBalance AG
    • Sonnenhügelstraße 8
    • 9240  Uzwil
    • Switzerland
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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