Trial document





This trial has been registered retrospectively.
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  DRKS00014762

Trial Description

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Title

Changes in sleep architecture in German Armed Forces personnel with posttraumatic stress disorder compared with depressed and healthy control subjects

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to differentiate between sleep disorders in soldiers with post traumatic stress disorder compared to healthy and depression- affected soldiers. The parameters of sleep latency, total duration of REM sleep and total duration of deep sleep should be investigated by means of polysomnography. Here, electrophysiological parameters will be used to detect sleep disorders. In addition to healthy volunteers, patients with depressive illness are also being examined as a control group, since sleep disturbances such as delayed falling asleep and early morning awakenings are regularly observed here.

The proposed project aims to evaluate whether there are specific differences in sleep disorders in soldiers with post- traumatic stress disorder compared to those with depression and a healthy control group.

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Brief Summary in Scientific Language

Background: This study compares the sleep architecture of patients with posttraumatic stress disorder (PTSD) with that of patients with depression and subjects with no mental disorder.
Method: 45 German Armed Forces personnel with PTSD, 72 German Armed Forces personnel with depression and 24 healthy control subjects underwent 24-hour polysomnography. The effects of group membership, medication and group x medication interaction were analysed for the following variables: sleep onset latency, REM sleep latency, slow-wave sleep and REM sleep percentages.
Results: Sleep onset latency was significantly prolonged in both the PTSD and the depression group. Moreover, psychotropic medication was associated with significantly prolonged REM sleep latency and the REM sleep period was longer in the PTSD group than in the depression group.
Conclusion: The impact on sleep onset latency is of special clinical relevance in that according to preliminary studies, it is of major importance for subjective sleep quality. Longer sleep onset latency in the PTSD group may not only be a trauma sequela, but may also be involved in maintaining the disorder.

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Organizational Data

  •   DRKS00014762
  •   2018/06/13
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  •   yes
  •   Approved
  •   PV4841, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   F32.1 -  Moderate depressive episode
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Interventions/Observational Groups

  •   Not only soldiers with deployment-related trauma were included in this study, but also those who developed PTSD with no (obvious) military context in accordance with ICD-10 diagnostic criteria. Within the "PTSD" and "depression" groups, subjects taking psychoactive or other long-term medication known to influence sleep were recorded and analysed separately. These include antidepressants (TCAs, SSRIs, SNRIs, NDRIs, NaSSAs), atypical neuroleptics (quetiapine), so-called Z drugs (zolpidem, zopiclone) and mood stabilisers (pregabalin). The control group of healthy subjects, i.e. subjects without a relevant history of preexisting psychiatric or neurological disorders, consisted of personnel of the Mental Health Centre at German Armed Forces Hospital Hamburg and/or Helmut Schmidt German Armed Forces University in Hamburg. We were thus able to generate a sample that, apart from the control group (6 civilians), consisted solely of German Armed Forces personnel, including 28 servicewomen and 113 servicemen. The average age was Mage = 30.3 years (SDage = 8.1). In terms of level of education, 17.8% had completed higher education (n = 25), 19.1% had a general university entrance qualification (n = 27), 52.5% an intermediate secondary school-leaving certificate (n = 74), 9.9% a lower secondary school-leaving certificate (n = 14) and 0.7% no school-leaving qualification (n= 1).
    At the outset, doctors informed the subjects of the scope and objective of the study (Annex 1, Information Sheet).
  •   The control groups in this study included not only healthy subjects but also soldiers with depressive disorders because they often experience sleep disorders such as delayed sleep onset, an increase in nighttime wake phases and early morning waking [10]. Moreover, there is evidence of an increased REM sleep percentage of sleep period time and reduced REM sleep latency with increased eye movement density, much like in PTSD patients [5, 31]. Depressive disorders are the most common secondary diagnosis in PTSD patients and are not considered a criterion for exclusion in many studies despite their known impact on sleep architecture. This study, however, excluded depression as a comorbidity and integrated patients with depression as a separate control group in the analyses.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The effects of group membership, medication and group x medication interaction were analysed for the following variables: sleep onset latency, REM sleep latency, slow-wave sleep and REM sleep percentages.

Polysomnography
The device used in this study for sleep monitoring was the Somnowatch TM plus ®. It includes a 6-channel electroencephalogram (F3, F4, C3, Cz, C4, P3, P4), an electromyogram to monitor muscle tone, an electrooculogram to track eye movements and actigraphy to monitor body positions and movements. Using this device, we can differentiate between REM sleep stages, sleep stage 1, sleep stage 2 and slow-wave sleep and determine their percentages of sleep duration and sequence throughout the sleep cycle.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2014/12/15
  •   141
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

A consecutive sample of patients with an ICD-10 diagnosis of posttraumatic stress disorder (F43.1) or depression (F32, F33) were recruited from the pool of regular inpatients at the Mental Health Centre at Bundeswehr Hospital Hamburg. Not only soldiers with deployment-related trauma were included in this study, but also those who developed PTSD with no (obvious) military context in accordance with ICD-10 diagnostic criteria.

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Exclusion Criteria

The following exclusion criteria were determined on the basis of ICD-10: psychotic disorder (F20-F29), manic episode, bipolar affective disorder (F30, F31), personality disorders (F60-F69), alcohol and/or drug addiction (F10-F19), neurological disease involving the central nervous system, sleep apnoea and other organic sleep disorders (G47.-) as well as nonorganic sleep disorders (F51.-) other than nightmares (F51.5). Furthermore, we excluded subjects who had been diagnosed with a comorbidity of the respective other group (i.e. PTSD or depression).

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Addresses

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    • Bundeswehrkrankenhaus Hamburg
    • Lesserstrasse 180
    • 22049  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf,Institut für Medizinische Psychologie, W26
    • Mr.  Prof.  Holger  Schulz 
    • Martinistraße 52
    • 20246  Hamburg
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    • Bundeswehrkrankenhaus Hamburg, Abteilung VIb
    • Mr.  Dr.  Robert  Gorzka 
    • Lesserstrasse 180
    • 22049  Hamburg
    • Germany
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    • Bundeswehrkrankenhaus Hamburg
    • Mr.  Dr.  Robert  Gorzka 
    • Lesserstrasse 180
    • 22049  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg Eppendorf Institut für Medizinische Pschologie
    • Mr.  Prof.  Holger  Schulz 
    • Martinistrasse
    • 20246  Hamburg
    • Germany
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    •   +49 (0) 40 7410-56806
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    •   schulz at uke.de
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/13
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Trial Publications, Results and other Documents

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