Trial document




This trial has been registered retrospectively.
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  DRKS00024127

Trial Description

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Title

Efficacy of hydrotherapy in non-organic sleep disorders

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Trial Acronym

hydrotherapy in non-organic sleep disorders

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URL of the Trial

https://www.fuessen.de/gesundheit/besser-schlafen/studie-hydrotherapie-schlaf.html

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Brief Summary in Lay Language

The aim of the project is to research hydrotherapy and its effect on the vegetative nervous system and non-organic sleep disorders with the help of an intervention study. The intervention will be monitored by biweekly HRV measurements as well as sleep diaries and other diagnostic questionnaires.
The planned outcome is to answer the question of whether a 12-week intervention with hydrotherapy can significantly affect non-organic sleep disorders more than a control group without intervention. Improving the study situation by evaluating and objectifying the effect of hydrotherapy on the vegetative nervous system creates important foundations for the tasks of the future.

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Brief Summary in Scientific Language

The research question is whether a 12-week intervention with hydrotherapy can significantly affect non-organic sleep disorders more than a control group without intervention.

The primary goal is to study the effects of hydrotherapy on non-organic sleep disorders.

The secondary objective is to investigate the effect of hydrotherapy on the vegetative nervous system.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00024127
  •   2021/11/23
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  •   no
  •   Approved
  •   18-888, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   GE9-2499-KuHeMo-19-V1  (Institut für Kurortmedizin und Gesundheitsförderung (IKOM))
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Health Condition or Problem studied

  •   F51.0 -  Nonorganic insomnia
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Interventions/Observational Groups

  •   intervention with hydrotherapy
  •   waiting group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

The primary goal is to study the effects of hydrotherapy on non-organic sleep disorders.
Primary targets are the values of the subjective sleep quality questionnaires in terms of falling asleep, falling asleep and waking up. For this purpose, the scores of the Pittsburgh Sleep Quality Index (PSQI – 0-21) (Buysse et al. and Riemann and Backhaus (1996) 1989) and the Questionnaire on Wellbeing WHO (five - version 1998 - 0-100%) are (Topp et s. 2015).

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Secondary Outcome

The secondary objective is to investigate the effect of hydrotherapy on the vegetative nervous system.

Secondary targets are the values of the heart rate variance in ms, with whose observation the change in the vegetative nervous system (sympathetic, parasympathetic) can be assessed (Schega 2010).
Another target is the reheating of a foot, whereby the temperature of the skin is measured at measuring points of the foot back and the big toe in degrees Celsius. This value is also considered to be a measurement of the effect of the vegetative nervous system, in particular autonomous heat regulation (Baier 1980).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/03/10
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

The study is carried out by people aged 18 to 70 who suffer from so-called non-organic sleep disorders. Complaints must be longer than four weeks. These sleep disturbances must not be caused by illness and/or medication.
The minimum value of the Pittsburgh Sleeping Quality Index must be a score of PSQI>4.

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Exclusion Criteria

Diseases to be excluded:
- Sleep apnea syndrome
- Restless Legs Syndrome
- Neurodegenerative diseases (e.B. Parkinson's disease, Alzheimer's disease)
- Mental illnesses
- Pain-related sleep disorder
- Other sleep disorder due to an organic disease
- Alcohol dependence

(b) Drugs to be excluded:
- Prescription sleeping pills (only with regular use, occasional use is allowed)
- Psychopharmaceuticals
- Psychostimulating drugs (e.B.
- Antiepileptics

(c) Other exclusion criteria:
- ongoing other treatment for insomnia.

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Addresses

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    • Therapiezentrum EggensbergerTräger: EGGENSBERGER OHG
    • Mr.  MSc  Andreas  Eggensberger 
    • Ringweg 6
    • 87629  Füssen - Hopfen am See
    • Germany
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    • Füssen Tourismus und Marketing/ "Kurverwaltung" Förderpartner der Studie
    • Mr.  Stefan  Fredlmeier 
    • Kaiser-Maximilian-Platz 1
    • 87629  Füssen
    • Germany
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    • Therapiezentrum Eggensberger
    • Mr.  Master of Science in Physiotherapie  Andreas  Eggensberger 
    • Ringweg 6
    • 87629  Füssen - Hopfen am See
    • Germany
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    • Therapiezentrum Eggensberger Ambulantes Rehazentrum Eggensberger
    • Mr.  Andreas  Eggensberger 
    • Ringweg 6
    • 87629  Füssen - Hopfen am See
    • Germany
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Sources of Monetary or Material Support

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    • Bayerischen Staatsministeriums für Gesundheit und Pflege Institut für Kurortmedizin und Gesundheitsförderung (IKOM)
    • Haidenauplatz 1
    • 81667  München
    • Germany
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    • Therapiezentrum Eggensberger EGGENSBERGER OHG
    • Mr.  MSc  Andreas  Eggensberger 
    • Ringweg 6
    • 87629  Füssen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.