SleepPhase 2PHOTONSNCT05116358
Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health
A Phase 2 study testing Phototherapy device in people with Sleep, run by University of Arizona at 1 site in United States.
Trial summary
There are few devices currently on the market claiming to improve sleep. This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Phototherapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 30 Jan 2022
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 60 years old
- Able to read and write fluently in English
- Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
- Access to a residential mailing address for shipping study materials
- Exhibit a score of >8 on the Insomnia Severity Index
- Self-report that they have a problem with their sleep that they wish to improve
Who cannot join
- Have a moderate to severe current sleep disorder
- Have a current psychiatric disorder
- Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants
- Have a medical condition that would interfere with their ability to complete all study procedures or would render measurements invalid (e.g., some autoimmune conditions, cardiac conditions, endocrine conditions, or chronic pain conditions)
- Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
- Exhibit a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am
Show all 13Show fewer
- Have not engaged in shift work for the past month, and will refrain from shift work during the study
- Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep
- Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study
- Regularly smoke or use other tobacco products
- Regularly use cannabis-derived medicinal products
- Are pregnant
- Are a full-time caregiver to an individual that requires attending during the evening and night
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Psychiatry, University of Arizona
Tucson, Arizona, 85719
Michael A Grandner, PhD, 520-626-6246, grandner@email.arizona.edu
Chloe CA Wills, 520 626 1737, chloecawills@psychiatry.arizona.edu
About this study
There are few devices currently on the market claiming to improve sleep. This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night.
Read the detailed description
This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night. Phototherapy has been shown to improve chronic pain, cerebral blood flow, neurological function, and capillary growth in skeletal muscle. A device worn at night may improve sleep onset, total sleep time, or modify sleep architecture. Improved cardiovascular function may facilitate a decrease in core body temperature needed for sleep onset. Relaxation from direct heat may help to decrease cortisol levels, thus reducing the number of night-time arousals. It may also decrease circulating levels of norepinephrine (NE), one of the main neurotransmitters involved in arousal. The aim of this study is to evaluate if the device worn leads to greater next-day wellbeing and cognitive function as a result of increased slow-wave activity.
- Conditions
- Sleep
- Being tested
- Phototherapy device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy deviceDevice
The active phototherapy device will emit light
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | An active phototherapy device Receives: Device: Phototherapy device |
| Sham (Placebo) | Sham comparator | An inactive device Receives: Device: Phototherapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective rating of the device across a 3-week intervention
There will be a subjective rating of the phototherapy device using a series of questions assessing device's effect on sleep and next-day function at the end of the trial.
Measured: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
Change in Insomnia Severity Index (ISI) scores across a 3-week intervention
The ISI is a 7-item insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.
Measured: Change from baseline over the course of the study (after 21 days of wearing the device)
Change in objective sleep efficiency across a 3-week intervention
Objective sleep efficiency will be measured with a wearable device (Oura ring) that is worn for the duration of the study and captures sleep and wake data using actigraphy.
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Secondary outcomes (11)
Change in mean sleep latency assessed using sleep diaries
Sleep latency, or time taken to fall asleep, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean sleep latency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in Karolinska Sleepiness Scale (KSS) score
The Karolinska Sleepiness Scale (KSS) measures situational sleepiness on a 9-point scale
Measured: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
Circadian Energy Scale (CIRENS) score
CIRENS is a very short and simple chronotype measurement tool based on energy. The CIRENS consists of two introspective questions about the usual energy level (very low, low, moderate, high, or very high, scored 1 to 5) in the morning and in the evening. The difference between energy level scores (-4 to 4) felt by respondents in the evening and morning defines the chronotype score and classification.
Measured: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Positive Affect
The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences. This scale will allow for separate assessment of impact on positive mood.
Measured: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Negative Affect
The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences. This scale will allow for separate assessment of impact on negative mood.
Measured: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Fatigue Severity Scale (FSS) across a three-week intervention
Fatigue Severity Scale (FSS) is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- "Strongly Disagree" to 7-"Strongly Agree".
Measured: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Profile of Mood States (POMS) across a three week intervention
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A total score will be evaluated in addition to the individual items.
Measured: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Wake After Sleep Onset (WASO) assessed using morning sleep diaries over the duration of the study
Wake after sleep onset (WASO), or the number of nocturnal awakenings, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean WASO during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
Sleep efficiency, or the amount of time spent asleep during a sleep opportunity, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean sleep efficiency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in total sleep time assessed using morning sleep diaries over the duration of the study
Total sleep time will be assessed using morning sleep diaries completed by the participant upon awakening. The mean total sleep time during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in morning refreshed feeling assessed using morning sleep diaries over the duration of the study
Morning refreshed feeling will be assessed using morning sleep diaries completed by the participant upon awakening. The mean refreshed feeling during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Measured: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start2 Sep 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II Interventional (Clinical Trial) Determine whether use of the light therapy device (versus sham device) results in changes to self-reported sleep quality, self-reported sleep continuity, objectively-estimated sleep continuity, and objectively-estimated sleep architecture. Additionally, to determine whether use of the light therapy device (versus placebo device) results in improvements in mood and daytime functioning .and induce improvements in mood, stress, morning energy levels, perceived daytime functioning, and fatigue levels.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- CeraZ LLC
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116358
- Sponsor's protocol ID
- 2012256803
- Acronym
- PHOTONS
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kennedy KER, Wills CCA, Holt C, Grandner MA. A randomized, sham-controlled trial of a novel near-infrared phototherapy device on sleep and daytime function. J Clin Sleep Med. 2023 Sep 1;19(9):1669-1675. doi: 10.5664/jcsm.10648.
PubMed 37141002
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health
- ClinicalTrials.gov ID
- NCT05116358
- Acronym / sponsor ID
- PHOTONS / 2012256803
- Conditions
- Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- CeraZ LLC
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
There are few devices currently on the market claiming to improve sleep. This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night.
Detailed description
This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night. Phototherapy has been shown to improve chronic pain, cerebral blood flow, neurological function, and capillary growth in skeletal muscle. A device worn at night may improve sleep onset, total sleep time, or modify sleep architecture. Improved cardiovascular function may facilitate a decrease in core body temperature needed for sleep onset. Relaxation from direct heat may help to decrease cortisol levels, thus reducing the number of night-time arousals. It may also decrease circulating levels of norepinephrine (NE), one of the main neurotransmitters involved in arousal. The aim of this study is to evaluate if the device worn leads to greater next-day wellbeing and cognitive function as a result of increased slow-wave activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Phase II Interventional (Clinical Trial) Determine whether use of the light therapy device (versus sham device) results in changes to self-reported sleep quality, self-reported sleep continuity, objectively-estimated sleep continuity, and objectively-estimated sleep architecture. Additionally, to determine whether use of the light therapy device (versus placebo device) results in improvements in mood and daytime functioning .and induce improvements in mood, stress, morning energy levels, perceived daytime functioning, and fatigue levels.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Phototherapy deviceAn active phototherapy device |
| Sham (Placebo) | Sham comparator | Device: Phototherapy deviceAn inactive device |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 60 years old
- Able to read and write fluently in English
- Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
- Access to a residential mailing address for shipping study materials
- Exhibit a score of >8 on the Insomnia Severity Index
Key exclusion criteria (13 listed)
- Have a moderate to severe current sleep disorder
- Have a current psychiatric disorder
- Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants
- Have a medical condition that would interfere with their ability to complete all study procedures or would render measurements invalid (e.g., some autoimmune conditions, cardiac conditions, endocrine conditions, or chronic pain conditions)
- Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
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 |
|---|---|---|
| Phototherapy deviceThe active phototherapy device will emit light | Device | Active, Sham (Placebo) |
Primary outcome
Change in subjective rating of the device across a 3-week intervention
Time frame: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
There will be a subjective rating of the phototherapy device using a series of questions assessing device's effect on sleep and next-day function at the end of the trial.
Change in Insomnia Severity Index (ISI) scores across a 3-week intervention
Time frame: Change from baseline over the course of the study (after 21 days of wearing the device)
The ISI is a 7-item insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.
Change in objective sleep efficiency across a 3-week intervention
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Objective sleep efficiency will be measured with a wearable device (Oura ring) that is worn for the duration of the study and captures sleep and wake data using actigraphy.
11 secondary outcomes
Change in mean sleep latency assessed using sleep diaries
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in Karolinska Sleepiness Scale (KSS) score
Time frame: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
Circadian Energy Scale (CIRENS) score
Time frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Positive Affect
Time frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Negative Affect
Time frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Fatigue Severity Scale (FSS) across a three-week intervention
Time frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Profile of Mood States (POMS) across a three week intervention
Time frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Wake After Sleep Onset (WASO) assessed using morning sleep diaries over the duration of the study
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in total sleep time assessed using morning sleep diaries over the duration of the study
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in morning refreshed feeling assessed using morning sleep diaries over the duration of the study
Time frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Derived from this study: PubMed 37141002Kennedy KER, Wills CCA, Holt C, Grandner MA. A randomized, sham-controlled trial of a novel near-infrared phototherapy device on sleep and daytime function. J Clin Sleep Med. 2023 Sep 1;19(9):1669-1675. doi: 10.5664/jcsm.10648.
- Individual participant dataSharing planned: Undecided
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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.
Department of Psychiatry, University of Arizona
Tucson, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phototherapy device in people with Sleep, run by University of Arizona 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective rating of the device across a 3-week intervention (time frame: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)). 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?
On the ClinicalTrials.gov record for NCT05116358, which also lists 1 linked publication.
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 11 Nov 2021.