Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health

NCT05116358 | Unknown Phase 2

• 1 other identifier: 2012256803
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..

• Circadian Energy Scale (CIRENS) score

  Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).

• Positive and Negative Affect Scales (PANAS) Positive Affect

  Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).

• Positive and Negative Affect Scales (PANAS) Negative Affect

  Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).

Study Arms (2)

Active

ACTIVE COMPARATOR

An active phototherapy device

Device: Phototherapy device

Sham (Placebo)

SHAM COMPARATOR

An inactive device

Device: Phototherapy device

Interventions

Phototherapy device DEVICE

The active phototherapy device will emit light

Active; Sham (Placebo)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Arizona: lead
• CeraZ LLC: collaborator

Study Sites (1)

Department of Psychiatry, University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37141002 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Phase II - Masked (Sham Controlled) Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Psychology, and Medicine; Director, Sleep & Health Research Program

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: September 2, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (1)