- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05342662
Light Sleep: Screen Use and Sleep Health (LS)
September 12, 2023 updated by: David Reichenberger, Penn State University
Evaluating the Consequences of Mistimed Light-emitting Device Use on Cardiac Activity and Sleep Health
The Phone Sleep Study is being done to find out whether wearing blue light-blocking glasses in the evening improves subsequent sleep.
This is a 21-day study and participants will be asked to wear a sleep-monitoring "actiwatch", a heart tracker, and an activity monitor, as well as to provide screenshots of participants' smartphone's screen time app for three weeks.
Participants will also be asked to wear a blood pressure cuff on their arm for three days during each week, for a total of nine days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
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
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Biobehavioral Health Building
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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 29 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Fluent English speaker and reader
- Capable of providing one's own informed consent
- Age 18 to 29 years old
- Healthy, sighted individuals
- Own an iOS smartphone (iPhone)
- Willingness to update smartphone to access the current version of the Screen Time or StayFree application, depending on smartphone operating system
- Willingness to participate in surveys, wear health monitoring devices, and provide screenshots of their smartphone's screentime application throughout the entire study
Exclusion Criteria:
- Younger than 18 or older than 29 years
- Individuals who are blind or wear corrective lenses
- Taking prescribed medications that affect sleep
- Recent shift work
- Sleep disorder diagnosis or any cardiovascular disease
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blue light-blocking glasses
Participants will wear blue light-blocking glasses to evaluate whether sleep behaviors improve.
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Participants will be randomly assigned to wear either blue light-blocking glasses or glasses with clear lenses during the second week of the study.
During the third week, participants will be assigned to wear the opposite pair of glasses.
Other Names:
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Placebo Comparator: Glasses with clear lenses
Participants will wear glasses with clear lenses to serve as the control condition.
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Non-blue light-blocking glasses
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep onset
Time Frame: Throughout the duration of the study (~3 weeks)
|
Midnight-centered clocktime of when participant falls asleep at night
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Throughout the duration of the study (~3 weeks)
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Sleep midpoint
Time Frame: Throughout the duration of the study (~3 weeks)
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Midnight-centered clocktime denoting the middle of the nocturnal sleep episode
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Throughout the duration of the study (~3 weeks)
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Total sleep time at night
Time Frame: Throughout the duration of the study (~3 weeks)
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Length of time spent asleep during the night, excluding time spent awake throughout the sleep episode
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Throughout the duration of the study (~3 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Reichenberger, MS, Department of Biobehavioral Health
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)
November 23, 2022
Primary Completion (Actual)
September 5, 2023
Study Completion (Actual)
September 5, 2023
Study Registration Dates
First Submitted
April 6, 2022
First Submitted That Met QC Criteria
April 18, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- STUDY00019746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All processed IPD data that underlie results in a publication
IPD Sharing Time Frame
Starting 1 year after the last publication based on collected data
IPD Sharing Access Criteria
Interested parties should contact David Reichenberger (reichenberger@psu.edu)
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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