NCT05408013

Brief Summary

The primary aim of the proposed project is to investigate the prevalence of insomnia in patients with psychiatric disorders treated as inpatients in psychiatric hospitals in two study sites in Switzerland and nine study sites in Germany. The secondary aim is to investigate whether there are demographic or disorder specific parameters that influence the prevalence of insomnia in patients with psychiatric disorders.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.8 years

First QC Date

October 28, 2021

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insomnia Disorder

    The prevalence of insomnia disorder will be assessed at a one-time point per patient during a study session with a clinician.

    Day 1

Study Arms (1)

ward patients in psychiatric hospitals

Patients in psychiatric hospitals will be assessed so that the prevalence of insomnia in psychiatric inpatients can be estimated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who suffer from a psychiatric disorder according to the DSM-5 and who are currently treated as inpatients in a psychiatric hospital

You may qualify if:

  • patients who suffer from a psychiatric disorder according to the DSM-5 and who are currently treated as inpatients in one of these psychiatric hospitals:
  • swiss study sites: Universitäre Psychiatrische Dienste in Bern, Privatklinik Meiringen.
  • german study sites: Freiburg, Ingolsatdt, Kiel, Klingenmünster, Leipzig, Mannheim, Nürnberg, Paderborn, Regensburg

You may not qualify if:

  • Age under 18 years
  • involuntary stay at the clinic
  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäre Psychiatrische Dienste Bern (Upd)

Bern, 3000 60, Switzerland

RECRUITING

Related Publications (1)

  • Seow LSE, Verma SK, Mok YM, Kumar S, Chang S, Satghare P, Hombali A, Vaingankar J, Chong SA, Subramaniam M. Evaluating DSM-5 Insomnia Disorder and the Treatment of Sleep Problems in a Psychiatric Population. J Clin Sleep Med. 2018 Feb 15;14(2):237-244. doi: 10.5664/jcsm.6942.

    PMID: 29394962BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Christoph Nissen, Prof. Dr. med

    Sleep Research in Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Nissen, Prof. Dr. med

CONTACT

Elisabeth Hertenstein, Dr. phil

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

October 28, 2021

First Posted

June 7, 2022

Study Start

July 1, 2021

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Participant data that underlie the results reported in the future article after deidentification will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
In the end of the study the coded data will be sent to Berlin and used for result calculations
Access Criteria
Encrypted data will be sent via secure mails to heidi.danker-hopfe@charite.de. The code to open the encrypted data will be sent via a separate mail. The methods are conform with the regulations of the ethics commission of Switzerland and Germany.

Locations