GlassesLSNCT05342662
Light Sleep: Screen Use and Sleep Health
A study testing Blue light-blocking glasses and Glasses with clear lenses in people with Glasses, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Glasses
- What is being tested?
- Blue light-blocking glasses and Glasses with clear lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2022to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biobehavioral Health Building
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Conditions
- Glasses
- Being tested
- Blue light-blocking glasses, Glasses with clear lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light-blocking glassesDevice
Also called Swanwick Night Swannies
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.
Glasses with clear lensesDevice
Also called Swanwick glasses
Non-blue light-blocking glasses
| Study group | Role | What they receive |
|---|---|---|
| Blue light-blocking glasses | Experimental | Participants will wear blue light-blocking glasses to evaluate whether sleep behaviors improve. Receives: Device: Blue light-blocking glasses |
| Glasses with clear lenses | Placebo comparator | Participants will wear glasses with clear lenses to serve as the control condition. Receives: Device: Glasses with clear lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset
Midnight-centered clocktime of when participant falls asleep at night
Measured: Throughout the duration of the study (~3 weeks)
Sleep midpoint
Midnight-centered clocktime denoting the middle of the nocturnal sleep episode
Measured: 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
Measured: Throughout the duration of the study (~3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start23 Nov 2022
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlassesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Reichenberger, Penn State University
- Investigators
- David Reichenberger, MS, Principal investigator, Department of Biobehavioral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342662
- Sponsor's protocol ID
- STUDY00019746
- Acronym
- LS
- Status last verified
- Sep 2023
- First submitted
- 6 Apr 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All processed IPD data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Consequences of Mistimed Light-emitting Device Use on Cardiac Activity and Sleep Health
- ClinicalTrials.gov ID
- NCT05342662
- Acronym / sponsor ID
- LS / STUDY00019746
- Conditions
- Glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blue light-blocking glasses | Experimental | Device: Blue light-blocking glassesParticipants will wear blue light-blocking glasses to evaluate whether sleep behaviors improve. |
| Glasses with clear lenses | Placebo comparator | Device: Glasses with clear lensesParticipants will wear glasses with clear lenses to serve as the control condition. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light-blocking glassesAlso: Swanwick Night SwanniesParticipants 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. | Device | Blue light-blocking glasses |
| Glasses with clear lensesAlso: Swanwick glassesNon-blue light-blocking glasses | Device | Glasses with clear lenses |
Primary outcome
Sleep onset
Time frame: Throughout the duration of the study (~3 weeks)
Midnight-centered clocktime of when participant falls asleep at night
Sleep midpoint
Time frame: Throughout the duration of the study (~3 weeks)
Midnight-centered clocktime denoting the middle of the nocturnal sleep episode
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes. All processed IPD data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Reichenberger, MS principal investigator
Department of Biobehavioral Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light-blocking glasses and Glasses with clear lenses in people with Glasses, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset (time frame: Throughout the duration of the study (~3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.