F51
Conditions
Interventions
Group 1: T1: Polysomnography - objective assessment tool, Sleep Diary and Questionnaires - subjective assessment tools
Group 2: T2: Polysomnography - objective assessment tool, Sleep Diary and Questio
Sponsors
Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: – written informed consent – insomnia disorder according to DSM-5 – age 18 to 65 years
Exclusion criteria
Exclusion criteria: – any current additional sleep disorder – any current additional psychiatric disease or suicide risk – clinically significant diseases that have an impact on outcome variables – existence of a severe or unstable medical disease identified by a standardized clinical interview – regular intake of any psychotropic substance known to affect sleep – any intake of sleep or psychotropic medication 2 weeks prior to and during the study – insufficient fluency in German to complete the questionnaires – night shift workers – pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency assessed by polysomnographic measurement will be the primary outcome. This data will be collected during the first and second polysomnography measurement. Primary analysis: Sleep efficiency determined by the polysomnographic measurement is the primary outcome of this study since it integrates information about objective sleep onset and sleep maintenance. The main research question (effect of vacation on sleep efficiency) will be investigated using a paired t-test comparing polysomnographic sleep efficiency between measurement points before and after vacation. Exploratory analyses: These will include tests for differences before and after vacation in other objective (sleep-onset latency, wake after sleep onset, number of awakenings and arousals, sleep architecture variables) and subjective (sleep-onset latency, wake after sleep onset, number of awakenings) sleep parameters. Different dimensions of work and life quality will also be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia severity will be assessed with the use of Insomnia Severity Index (ISI), as well as with a sleep diary. Depressive symptoms will be assessed with the Beck Depression Inventory (BDI) and the Epworth Sleepiness Scale (ESS) and the Multidimensional Fatigue Inventory (MFI) will be used to measure daytime sleepiness. The Glasgow Sleep Effort Scale will be used to assess the degree of dysfunctional explicit effort to fall asleep. The Glasgow Sleep Impact Index will be used to assess sleep-related quality of life. The State-Trait Anxiety Inventory (STAI) will be used to measure anxiety in a current state (“feeling right now”) as well as an enduring trait (“generally feel”). The brief version of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) is used to evaluate the role of sleep-related beliefs and attitudes in insomnia. The Pre-Sleep state of the participant will be assessed with the Pre-Sleep Arousal Scale (PSAS). The chronotype of the participants will be tested with the use of Morningness-Eveningness Questionnaire (MEQ). The health status will be measured with The Short Form (36) Health Survey (SF36). Quality of work from the perspective of the employees will be measured with DGB-Index Gute Arbeit. Productivity at work will be assessed with Work Productivity and Activity Impairment Questionnaire (WPAI). Job Satisfaction Index (JSI), as well as “Der Arbeitsbeschreibungsbogen” (ABB) will both be used to provide data on job satisfaction. | — |
Countries
Germany
Contacts
Public ContactNatasza Walter
Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed