NCT05342662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

April 6, 2022

Last Update Submit

September 12, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sleep onset

    Midnight-centered clocktime of when participant falls asleep at night

    Throughout the duration of the study (~3 weeks)

  • Sleep midpoint

    Midnight-centered clocktime denoting the middle of the nocturnal sleep episode

    Throughout the duration of the study (~3 weeks)

  • Total sleep time at night

    Length of time spent asleep during the night, excluding time spent awake throughout the sleep episode

    Throughout the duration of the study (~3 weeks)

Study Arms (2)

Blue light-blocking glasses

EXPERIMENTAL

Participants will wear blue light-blocking glasses to evaluate whether sleep behaviors improve.

Device: Blue light-blocking glasses

Glasses with clear lenses

PLACEBO COMPARATOR

Participants will wear glasses with clear lenses to serve as the control condition.

Device: Glasses with clear lenses

Interventions

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.

Also known as: Swanwick Night Swannies
Blue light-blocking glasses

Non-blue light-blocking glasses

Also known as: Swanwick glasses
Glasses with clear lenses

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biobehavioral Health Building

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • David Reichenberger, MS

    Department of Biobehavioral Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be told that both pairs of glasses block blue light.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 25, 2022

Study Start

November 23, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

All processed IPD data that underlie results in a publication

Shared Documents
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)

Locations