Trial document




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  DRKS00008965

Trial Description

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Title

Perception of sleep in good sleepers and patients with insomnia - part 2

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Trial Acronym

PERSLEEP 2

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URL of the Trial

http://nicht verfügbar

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Brief Summary in Lay Language

This study investiigates the perecption of sleep in good sleepers (n=47) and patients with insomnia (n=47) in realtion to obejctive parameters (polysomnography). To this end, both groups of subjects will be investigated for four consecutivee nights in the sleep laboratory of Freiburg University Hospital for Psychiatry and Psychotherapy.In the first and second night polysomnographic investigations will be performed. In the third and fourth night the method of event related potentials will be applied in additon to measure the reactivity of the brain via EEG to these stimuli. This includes the presentation of tones throughout the night and measurement of brain waves. We assume that patients with insomnia display altered characteristics of EEG responses which are related to their altered perception of sleep in compariosn to good sleepers.

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Brief Summary in Scientific Language

The first funding period of this study aimed at clarifying whether the frequently replicated finding of a marked discrepancy between
objective (polysomnographic) and subjective (questionnaires) sleep measurement in patients with insomnia is related to audiographically measured waking thresholds and can be elucidated by directly
questioning patients at nocturnal awakenings. 27 patients with insomnia and 27 good sleepers were investigated for four consecutive
nights in the sleep laboratory; in nights 3 and 4, according to a balanced design, three awakenings were performed during NonREMSleep (stage 2) and REM-Sleep. Contrary to our hypothesis, audiographically determined waking thresholds did not differ between both groups for stage 2 or REM sleep. Corresponding to our initial
assumption we found that awakenings from stage REM in contrast to stage 2 were significantly more frequently judged as being awake (in contrast to having slept) for REM sleep vs. stage 2 in patients with
insomnia. These data support our hypothesis of an instability of REM sleep as possible explanation for the altered perception of sleep in insomnia. This hypothesis was based on own data revealing an increased frequency of micro-arousals in insomnia especially during
REM sleep. In the second funding period we aim at further experimentally testing this hypothesis by applying an acoustic event
related potentials (ERP) paradigm. Good sleepers and patients with insomnia, after an adaptation and a baseline night, will undergo two further nights in the sleep laboratory with continous measurement of acoustically event-related potentials. ERP methodology has the
advantage of offering many more measurement points during the night relating to NonREM and REM sleep as compared to distinct awakenings, thus allowing a more precise characterization of the response characteristics of the brain (N1/ P2) to acoustic stimuli. We assume, analogous to our preliminary work, that response
characteristics especially during REM sleep will be fundamentally altered compared to NonREM sleep. Elucidating these issues does
not seem only of theoretical relevance for the question of how consciousness is experienced during the night but might also be of
clinical and therapeutical relevance for insomnia.

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

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008965
  •   2015/11/17
  •   [---]*
  •   yes
  •   Approved
  •   361/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F51.0 -  Nonorganic insomnia
  •   Healthy Sleepers
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Interventions/Observational Groups

  •   Patients with Insomnia
    This study investiigates the perecption of sleep in good sleepers (n=47) and patients with insomnia (n=47) in realtion to obejctive parameters (polysomnography). To this end, both groups of subjects will be investigated for four consecutivee nights in the sleep laboratory of Freiburg University Hospital for Psychiatry and Psychotherapy.In the first and second night polysomnographic investigations will be performed. In the third and fourth night the method of event related potentials will be applied in additon to measure the reactivity of the brain via EEG to these stimuli. This includes the presentation of tones throughout the night and measurement of brain waves. We assume that patients with insomnia display altered characteristics of EEG responses which are related to their altered perception of sleep in compariosn to good sleepers.
  •   Healthy Sleepers
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

P2 amplitude as measured with event related potentials

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Secondary Outcome

N1 amplitude as measured with event-related potentials

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/01/04
  •   94
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   60   Years
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Additional Inclusion Criteria

• Age 30 to 60 years (a limited age range seems adequate in order to avoid marked age-related confounds)
• For the patient group: ID diagnosis (DSM 5, APA, 2013) and a mismatch between subjective and objective total sleep time of at least 60 minutes (i.e. in the direction of a subjective underestimation of TST). Subjective TST will be derived from the 14 day sleep diary and will be contrasted to the PSG derived TST of the baseline night.
• Normal hearing (as determined by audiometry)
• Signed informed consent

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Exclusion Criteria

• Psychiatric diseases (acute/ lifetime) in the control group (evaluated with the SCID-I)
• Other acute and lifetime psychiatric diseases apart from Insomnia Disorder in the patient group (evaluated with the SCID-I)
• Sleep disorders according to the International Classification of Sleep Disorders (ICSD-3; AASM, 2013) in the control group (evaluated by a clinical interview and a polysomnographic investigation in the sleep laboratory of the Department of Psychiatry and Psychotherapy)
• Other sleep disorders apart from primary insomnia according to the International Classification of Sleep Disorders (ICSD-3; AASM, 2013) in the patient group (evaluated by a clinical interview and a polysomnographic investigation in the sleep laboratory of the Centre for Mental Disorders - see also description of sleep recordings for details)
• Shift work or transmeridian flights within the last 4 weeks and irregular sleep-wake rhythms (frequent shifts of bedtimes > 1 hour)
• Regular intake of any psychotropic substance known to affect sleep within the two weeks before the investigation or during the participation in this study; or ongoing psychotherapy
• Pregnancy or lactation
• Clinically significant, severe or unstable medical diseases that have an impact on sleep

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Addresses

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    • Abteilung für Klinische Psycholgie und PsychophysiologieKlinik für Psychiatrie und PsychotherapieUniversitätsklinik Freiburg
    • Mr.  Prof. Dr. Dipl. Psych.  Dieter  Riemann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Abteilung für Klinische Psycholgie und PsychophysiologieKlinik für Psychiatrie und PsychotherapieUniversitätsklinik Freiburg
    • Mr.  Prof. Dr. Dipl. Psych.  Dieter  Riemann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
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    • Abteilung für Klinische Psycholgie und PsychophysiologieKlinik für Psychiatrie und PsychotherapieUniversitätsklinik Freiburg
    • Mr.  Prof. Dr. Dipl. Psych.  Dieter  Riemann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.