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REM-sleep disruption and changes in noradrenergic neuronal reaction patterns in patients with sleep disorders or major depression

REM-sleep disruption and changes in noradrenergic neuronal reaction patterns in patients with sleep disorders or major depression - VNS sleep

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016537
Enrollment
45
Registered
2019-01-14
Start date
2018-10-08
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F33.2 F51.0

Interventions

Group 1: In MDD patients prior to and following implantation of vagal nerve stimulation LC function will be assessed using REM sleep parameters, pupillometry and reaction to acustically evoked potenti

Sponsors

Klinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: •Ability to provide written informed consent •Patients with MDD, eligible for and scheduled for treatment with VNS or Patients with ID or healthy controls

Exclusion criteria

Exclusion criteria: •Acute suicidal ideations •Ongoing substance abuse •For controls: current relevant psychiatric (for ID patients other than ID) or somatic disorder or recurring psychiatric disorder in the past •Somatic medication potentially confounding outcome variable besides stable psychiatric medication in patients with MDD

Design outcomes

Primary

MeasureTime frame
a)REML, REM (min), REM (%), REMD, EOGS, REM cycles b)P3 amplitude, baseline pupil diameter c)Change in BDI/HAMD/MADRAS baseline/12/18 months

Secondary

MeasureTime frame
a) NREM sleep parameters b) Spectral EEG sleep parameters c) Wake spectral EEG parameters d) Stimulation intensities e) Subjective assessments of sleep and depression f) Comparison to healthy controls and patients with insomnia disorder

Countries

Germany

Contacts

Public ContactLukas Frase

Klinik für Psychiatrie und Psychotherapie

psy.vns-studien@uniklinik-freiburg.de076127065010

Outcome results

None listed

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