- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02665247
Impact of Sleep Workshops in College Students
July 5, 2022 updated by: NYU Langone Health
The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood, anxiety and well-being measures in a sample of college students.
College students have a high prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and insomnia.
Sleep disorders in college students negatively affect mood, social functioning, physical safety, and academic performance.
Rarely recognized by the students themselves, these conditions are therefore often untreated.
Participants in this study will be randomly assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session.
Participants will be asked to track their sleep as well as complete questionnaires; a subset of participants will be asked to wear an activity monitor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently enrolled in classes at the NYU Washington Square campus
Exclusion Criteria:
- Students previously enrolled in the "While You Were Sleeping" course at NYU
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C-SIP
Participants assigned to the C-SIP group will attend sessions where information about sleep is presented.
In session I, information about sleep and the effects of lack of sleep will be presented.
Participants will also be presented with advice and tips on how to improve sleep.
Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.
|
In session I, information about sleep and the effects of lack of sleep will be presented.
Participants will also be presented with advice and tips on how to improve sleep.
Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.
|
Other: Control Session
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
|
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Epworth Sleepiness Scale (ESS) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Fatigue Severity Scale (FSS) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Health Behaviors Survey (HBS) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Perceived Stress Scale (PSS) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Sleep Hygiene Index (SHI) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Change in Sleep Student Behavior Survey (SSBS) score from baseline
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jess Shatkin, NYU Langone Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2016
Primary Completion (Actual)
November 24, 2019
Study Completion (Actual)
November 24, 2019
Study Registration Dates
First Submitted
January 22, 2016
First Submitted That Met QC Criteria
January 22, 2016
First Posted (Estimate)
January 27, 2016
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00847
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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