Trial document





This trial has been registered retrospectively.
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  DRKS00016911

Trial Description

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Title

Influence of sleep site on subjective and objective sleep quality, body temperature and subjective well-being

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of this study is to investigate the subjective and objective sleep quality, core-body temperature and changes of physiological parameters (heart and brain activity)
with regards to two different sleep sites: A standard cold-foam mattress vs. a gel-layered "climatised" high-heat capacity mattress ("Technogel")

Study subjects were healthy males aged 45-65 year. Goal n=33

Polysomnografic sleep recoding and measurement of several temperature values (body core, body surface, mattress surface) will be performed on middleaged healthy men, who will sleep on each mattress with a 1-week interval.

Goal variables are:

- objective sleep quality (esp. analysis of deep sleep stages "SWS"
- objective body core temperature
- objective body surface temperature
- subjective sleep quality
- subjective comfort

Main hypothesis:
- latency of deep sleep (SWS) is smaller in the Technogel condition compared to the standard condition

secondary hypotheses:
- a higher amount of deep-sleep can be found in the Technogel condition compared to the standard condition
- the Technogel condition shows a larger average decrease of core body temperature compared to the standard condition

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Brief Summary in Scientific Language

Prospective, double-blinded cross-over study with randomisation to groups A and B.
Participants sleep one night on each mattress, the standard mattress, and after one week "washout"-phase, the Technogel, and vice versa for the other group.
The order of the sequence / group allocation is randomised.
The objective analysis of sleep quality during sleep is performed using polysomnography (PSG), which is used routinely in sleep medicine diagnostic clinical routine.

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Organizational Data

  •   DRKS00016911
  •   2019/03/15
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  •   yes
  •   Approved
  •   EA1/316/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Sleep quality under temperature change
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Interventions/Observational Groups

  •   1 night Technogel, 1 week break, 1 night standard
  •   1 night standard, 1 week break, 1 night Technogel
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Changes of core body temperature, as well as body surface and mattress surface temperature
(temperature measurement by Vitalsense Core Temp. Capsule (Hidalgo Ltd., Cambridge, UK), as well as furface temperature sensors "iButtons", Maxim, Dallas, USA)

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Secondary Outcome

Changes in phsyiological parameters (hear rate, EEG-Frequencies by polysomnographic measurement, Embla PSG system)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/15
  •   33
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   45   Years
  •   65   Years
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Additional Inclusion Criteria

Written consent of study aprticipants after oral and written information

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Exclusion Criteria

Known sleep disorder requiring treatment
substance or alcohol abuse
acute-of chronic disease requiring treatment
treatment with hypnotic medications influencing the sleep-wake center
known slow digestive speed, obstipation
known diverticuli/ intestinal obstructions
previous complicated abdominal surgery
Acute or chronic intestinal disease
planned MRI within the study participation period

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Advanced Sleep Research GmbH
    • Luisenstr 54/55
    • 10117  Berlin
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    • Interdisziplinäres Schlafmedizinisches Zentrum der Charité
    • Mr.  Dr. med.  Sebastian  Herberger 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Interdisziplinäres Schlafmedizinisches Zentrum der Charité
    • Mr.  Dr. med.   Sebastian  Herberger 
    • Charitéplatz 1
    • 1117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Technogel Italia
    • Via Bassanes Inferiore 32
    • 36050  Pozzoleone (Vl)
    • Italy
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    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Mr.  Prof. Dr.  Ingo  Fietze 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/01
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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.