Efficacy of hydrotherapy in non-organic sleep disorders
- Conditions
- F51.0Nonorganic insomnia
- Registration Number
- DRKS00024127
- Lead Sponsor
- Therapiezentrum EggensbergerTräger: EGGENSBERGER OHG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 135
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary goal is to study the effects of hydrotherapy on non-organic sleep disorders.<br>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 Measures
Name Time Method The secondary objective is to investigate the effect of hydrotherapy on the vegetative nervous system.<br><br>Here, too, measurements take place at ten points in time (t0-t9). The first three months are measured every two weeks, then after one, after three and then six months.<br><br>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).<br>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).