- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05408013
The Prevalence of Insomnia in Patients With Psychiatric Disorders
Study Overview
Status
Conditions
Detailed Description
QUALITY ASSURANCE PLAN & SOURCE DATA VERIFICATION
For quality assurance the Ethics Committee may visit the research sites. For each study participant, a paper based case report form (CRF) will be maintained. CRFs will be kept current to reflect subject status at each phase during the course of study. Data for statistical analysis will be stored in an electronic database. Data will be transferred manually from the paper CRF to the electronic data base. As for the paper based CRF, the data stored electronically will not contain any personal information by which the participant can be identified. Only trained project personnel will be authorized for entries into the electronic database and authorized persons will be identifiable for every entry they made. Routinely collected data during daily clinical practice will be transferred to the participant CRF (e.g. diagnoses and medication).
DATA DICTIONARY
BASEC, Business Administration System for Ethical Committees CRF, Case report form FOPH, Federal Office of Public Health HRA, Human Research Act HRO, Ordinance on Human
STANDARD OPERATING PROCEDURE The recruitment of the study participants is consecutive. In all study sites, all newly admitted patients will be registered on a list each day. This list will be available for the study physicians. From this list, patients who are visibly not eligible (involuntary stay, under custody) will be deleted. Depending on the capacities of the study physicians, within three days after admission, 1-15 patients will be selected from the patients remaining on the list per day. The selected patients will be asked whether they agree to participate in the study.
The overall project duration will be 12 months starting the 1st of July 2021 until the end of June 2022. The patients will be screened according to the inclusion and exclusion criteria. The study investigator will then hold one session of 20 to 60 minutes with each participant filling out the following questionnaires:
- The study information and the informed consent
- The informed consent about the further use of the patient data
- Demographic data and general patient documentations
- PSQI: Pittsburgh sleep quality index
- ISI: Insomnia severity index
- The Epworth Sleepiness Scale
- SF-12: Short form 12 questionnaire about the subjective health status
- PHQ-9: Patient health questionnaire 9
- Fatigue Severity Screening
Participants will be withdrawn from the study immediately if there are any concerns about the participants' safety. Participants can also choose to withdraw from the study at any time, and are not required to provide their reason for withdrawing from the study. Coded data acquired before withdrawal will be analyzed as described in the participant information sheet.
If a serious event occurs, the research project will be interrupted and the Ethics Committee notified on the circumstances via BASEC within 7 days according to HRO Art. 21 .
SAMPLE SIZE ASSESSMENT & STATISTICAL ANALYSIS PLAN
In Table 1 in the study protocol which is attached in the documents section, the 95%- confidence intervals for prevalence in the range from 15% (p=0.15) to 25% (p=0.25) can be seen for sample sizes of n= 200, n= 250, n=300 and n= 500 patients. In consideration of the accuracy of the estimation of varying prevalence, the planned study aims to investigate 500 psychiatric inpatients. The named sample size will be sufficient to estimate prevalence rates with sufficient power.
PLAN FOR MISSING DATA Dropouts will be replaced by recruitment of new participants until the target sample size has been achieved.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christoph Nissen, Prof. Dr. med
- Phone Number: + 41 (0)31 930 9111
- Email: christoph.nissen@upd.ch
Study Contact Backup
- Name: Elisabeth Hertenstein, Dr. phil
- Phone Number: +41 (0)31 930 9502
- Email: elisabeth.hertenstein@upd.ch
Study Locations
-
-
-
Bern, Switzerland, 3000 60
- Recruiting
- Universitäre Psychiatrische Dienste Bern (Upd)
-
Contact:
- Prof. Dr. med. Christoph Nissen
- Phone Number: + 41 (0)31 930 9111
- Email: christoph.nissen@upd.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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:
2 swiss study sites: Universitäre Psychiatrische Dienste in Bern, Privatklinik Meiringen.
9 german study sites: Freiburg, Ingolsatdt, Kiel, Klingenmünster, Leipzig, Mannheim, Nürnberg, Paderborn, Regensburg
Exclusion Criteria:
- Age under 18 years
- involuntary stay at the clinic
- unable to give informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
ward patients in psychiatric hospitals
Patients in psychiatric hospitals will be assessed so that the prevalence of insomnia in psychiatric inpatients can be estimated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Disorder
Time Frame: Day 1
|
The prevalence of insomnia disorder will be assessed at a one-time point per patient during a study session with a clinician.
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christoph Nissen, Prof. Dr. med, Sleep Research in Psychiatry
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (ID 2020-01992)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia
-
Leiden UniversityBioClock Consortium; Caring UniveristiesCompleted
-
National Science Council, TaiwanCompleted
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Massachusetts General HospitalNational Institutes of Health (NIH)Completed
-
IpsenCompletedThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)InsomniaRussian Federation
-
Charite University, Berlin, GermanyCompleted
-
Roxane LaboratoriesCompleted
-
Butler HospitalSunovionCompleted