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

Not Applicable

• Conditions: Healthy Sleepers; F51.0; Nonorganic insomnia

• Registration Number: DRKS00008965
• Lead Sponsor: Abteilung für Klinische Psycholgie und PsychophysiologieKlinik für Psychiatrie und PsychotherapieUniversitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-17
• Study Completion: 2018-12-31
• Results First Posted: 2021-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
P2 amplitude as measured with event related potentials

Secondary Outcome Measures

Name	Time	Method
1 amplitude as measured with event-related potentials