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Sleep as a Biomarker – Transdiagnostic and Disorder-Specific Sleep Patterns in Mental Disorders

Sleep as a Biomarker – Transdiagnostic and Disorder-Specific Sleep Patterns in Mental Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038385
Enrollment
800
Registered
2026-03-13
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51.0 F32 F33 F40 F41

Interventions

Group 1: Observational group – patients with non-organic insomnia (ICD-10: F51.0)
no intervention, retrospective analysis of clinical polysomnographic and psychometric data. Group 2: Observational group – patients with a depressive episode or recurrent depressive disorder (ICD-10:
no intervention, retrospective analysis of clinical polysomnographic and psychometric data. Group 3: Observational group – patients with phobic or other anxiety disorders (ICD-10: F40.x, F41.x)
no intervention, retrospective analysis of clinical polysomnographic and psychometric data. Group 4: Healthy control group
no intervention, retrospective analysis of polysomnographic and psychometric data.

Sponsors

Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of one of the following disorders according to ICD-10: o Non-organic insomnia (F51.0) o Phobic or other anxiety disorders (F40.x, F41.x) o Depressive episode or recurrent depressive disorder (F32.x, F33.x)

Exclusion criteria

Exclusion criteria: • History of another sleep disorder (e.g., sleep apnea syndrome, restless legs syndrome [RLS], periodic limb movements during sleep [PLMS], REM sleep behavior disorder [RBD], narcolepsy); exception: nightmare disorder • Use of medications affecting the central nervous system known to affect sleep (within the last two weeks prior to or during the sleep laboratory assessment) • Severe medical conditions that may affect sleep • Irregular sleep–wake schedule or shift work including night shifts within the last four weeks prior to the assessment • Pregnancy • Evidence of PLMS with an arousal index > 5 events/hour or apnea index > 5 events/hour • Severe or unstable psychiatric comorbidities that may affect sleep, including organic and symptomatic mental disorders (ICD-10: F00–F09), substance use disorders (ICD-10: F10–F19), as well as schizophrenia, schizotypal, and delusional disorders (ICD-10: F20–F29)

Design outcomes

Primary

MeasureTime frame
Comparison of sleep macro- and microstructure between diagnostic groups and healthy controls. The analysis is based on routine polysomnographic data and includes: •Sleep continuity (sleep duration, sleep efficiency, sleep latency, wake time after sleep onset, number of awakenings) •Sleep architecture (distribution of sleep stages: Wake, NREM1–3, REM) •REM parameters (REM latency, REM duration, REM density) •EEG microstructure (spectral analysis of power in the frequency bands Delta, Theta, Alpha, Sigma, Beta, Gamma)

Secondary

MeasureTime frame
Associations between the primary outcomes (polysomnographic sleep parameters) and the results of psychometric self-report questionnaires within and across groups: • Insomnia Severity Index (ISI) • Beck Depression Inventory (BDI) • Pittsburgh Sleep Quality Index (PSQI) • State-Trait Anxiety Inventory (STAI)

Countries

Germany

Contacts

Public ContactLukas Spille

Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie

lukas.spille@uniklinik-freiburg.de+49 761 270-69781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026