Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT05363995
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial i-Sleep & BioClock Intervention
Sponsor:
Leiden University
Organization:
Study Overview
Official Title:
Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
Detailed Description:
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: