Trial document
This trial has been registered retrospectively.
DRKS00024127
Trial Description
Title
Efficacy of hydrotherapy in non-organic sleep disorders
Trial Acronym
hydrotherapy in non-organic sleep disorders
URL of the Trial
https://www.fuessen.de/gesundheit/besser-schlafen/studie-hydrotherapie-schlaf.html
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.
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.
Do you plan to share individual participant data with other researchers?
No
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
Secondary IDs
- GE9-2499-KuHeMo-19-V1 (Institut für Kurortmedizin und Gesundheitsförderung (IKOM))
Health Condition or Problem studied
- F51.0 - Nonorganic insomnia
Interventions/Observational Groups
- intervention with hydrotherapy
- waiting group
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
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).
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).
Countries of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
Recruitment
- Actual
- 2020/03/10
- 80
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 70 Years
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.
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.
Addresses
-
start of 1:1-Block address primary-sponsor
- Therapiezentrum EggensbergerTräger: EGGENSBERGER OHG
- Mr. MSc Andreas Eggensberger
- Ringweg 6
- 87629 Füssen - Hopfen am See
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 8362 9103 300
- +49 8362 9103 462
- kneippstudie at reha-hopfen.de
- http://www.reha-hopfen.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Füssen Tourismus und Marketing/ "Kurverwaltung" Förderpartner der Studie
- Mr. Stefan Fredlmeier
- Kaiser-Maximilian-Platz 1
- 87629 Füssen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 0836293850
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- s.fredlmeier at fuessen.de
- http://www.fuessen.de
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Therapiezentrum Eggensberger
- Mr. Master of Science in Physiotherapie Andreas Eggensberger
- Ringweg 6
- 87629 Füssen - Hopfen am See
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049 8362 9103-613
- 0049 8362 9103-462
- a.eggensberger at eggensberger.de
- http://www.reha-hopfen.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Therapiezentrum Eggensberger Ambulantes Rehazentrum Eggensberger
- Mr. Andreas Eggensberger
- Ringweg 6
- 87629 Füssen - Hopfen am See
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049 8362 9103-613
- 0049 8362 9103-678
- therapie at eggensberger.de
- http://www.reha-hopfen.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bayerischen Staatsministeriums für Gesundheit und Pflege Institut für Kurortmedizin und Gesundheitsförderung (IKOM)
- Haidenauplatz 1
- 81667 München
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- + 49 89 540233-0
- +49 89 540233-
- ikom at lgl.gyern.de
- https://www.stmgp.bayern.de/
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Therapiezentrum Eggensberger EGGENSBERGER OHG
- Mr. MSc Andreas Eggensberger
- Ringweg 6
- 87629 Füssen
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- 083629103777
- 083629103462
- a.eggensberger at eggensberger.de
- http://www.reha-hopfen.de
end of 1:1-Block address contact otherSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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