Light Sleep: Screen Use and Sleep Health (LS)

• ClinicalTrials.gov Identifier: NCT05342662
• Recruitment Status: Recruiting
• First Posted: April 25, 2022
• Last Update Posted: January 10, 2023
• Sponsor: Penn State University
• Information provided by (Responsible Party): David Reichenberger, Penn State University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Glasses	Device: Blue light-blocking glasses; Device: Glasses with clear lenses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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. Sleep and wake behaviors are the primary study outcome.
• Masking: Single (Participant)
• Masking Description: Participants will be told that both pairs of glasses block blue light.
• Primary Purpose: Other
• Official Title: Evaluating the Consequences of Mistimed Light-emitting Device Use on Cardiac Activity and Sleep Health
• Actual Study Start Date: November 23, 2022
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Blue light-blocking glasses; Participants will wear blue light-blocking glasses to evaluate whether sleep behaviors improve.	Device: Blue light-blocking glasses; 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 Name: Swanwick Night Swannies
Placebo Comparator: Glasses with clear lenses; Participants will wear glasses with clear lenses to serve as the control condition.	Device: Glasses with clear lenses; Non-blue light-blocking glasses; Other Name: Swanwick glasses

Outcome Measures

Primary Outcome Measures :

1. Sleep onset [ Time Frame: Throughout the duration of the study (~3 weeks) ]
   Midnight-centered clocktime of when participant falls asleep at night
2. Sleep midpoint [ Time Frame: Throughout the duration of the study (~3 weeks) ]
   Midnight-centered clocktime denoting the middle of the nocturnal sleep episode
3. Total sleep time at night [ Time Frame: Throughout the duration of the study (~3 weeks) ]
   Length of time spent asleep during the night, excluding time spent awake throughout the sleep episode

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 29 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Fluent English speaker and reader
2. Capable of providing one's own informed consent
3. Age 18 to 29 years old
4. Healthy, sighted individuals
5. Own an iOS smartphone (iPhone)
6. Willingness to update smartphone to access the current version of the Screen Time or StayFree application, depending on smartphone operating system
7. Willingness to participate in surveys, wear health monitoring devices, and provide screenshots of their smartphone's screentime application throughout the entire study

Exclusion Criteria:

1. Younger than 18 or older than 29 years
2. Individuals who are blind or wear corrective lenses
3. Taking prescribed medications that affect sleep
4. Recent shift work
5. Sleep disorder diagnosis or any cardiovascular disease

Contacts and Locations

Contacts

Contact: David Reichenberger, MS; 8175210634; reichenberger@psu.edu

Locations

United States, Pennsylvania

Biobehavioral Health Building; Recruiting

University Park, Pennsylvania, United States, 16802

Contact: David Reichenberger, MS reichenberger@psu.edu

Principal Investigator: David Reichenberger, MS

Sub-Investigator: Anne-Marie Chang, PhD

Sponsors and Collaborators

Penn State University

Investigators

• Principal Investigator: David Reichenberger, MS; Department of Biobehavioral Health

More Information

• Responsible Party: David Reichenberger, Principal Investigator, Penn State University
• ClinicalTrials.gov Identifier: NCT05342662
• Other Study ID Numbers: STUDY00019746
• First Posted: April 25, 2022
• Last Update Posted: January 10, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All processed IPD data that underlie results in a publication
• Supporting Materials: Analytic Code
• Time Frame: Starting 1 year after the last publication based on collected data
• Access Criteria: Interested parties should contact David Reichenberger (reichenberger@psu.edu)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors