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

NCT ID: NCT05116358

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2022-01-30

Brief Summary

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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

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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

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Phase II - Masked (Sham Controlled) Single (Participant)

Study Groups

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Active

An active phototherapy device

Group Type ACTIVE_COMPARATOR

Phototherapy device

Intervention Type DEVICE

The active phototherapy device will emit light

Sham (Placebo)

An inactive device

Group Type SHAM_COMPARATOR

Phototherapy device

Intervention Type DEVICE

The active phototherapy device will emit light

Interventions

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Phototherapy device

The active phototherapy device will emit light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 18 and 60 years old
2. Able to read and write fluently in English
3. Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
4. Access to a residential mailing address for shipping study materials
5. Exhibit a score of \>8 on the Insomnia Severity Index
6. Self-report that they have a problem with their sleep that they wish to improve

Exclusion Criteria

1. Have a moderate to severe current sleep disorder
2. Have a current psychiatric disorder
3. Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants
4. 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)
5. Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
6. Exhibit a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am
7. Have not engaged in shift work for the past month, and will refrain from shift work during the study
8. Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep
9. Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study
10. Regularly smoke or use other tobacco products
11. Regularly use cannabis-derived medicinal products
12. Are pregnant
13. Are a full-time caregiver to an individual that requires attending during the evening and night
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CeraZ LLC

UNKNOWN

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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MICHAEL A GRANDNER

Assistant Professor of Psychiatry, Psychology, and Medicine; Director, Sleep & Health Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry, University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Michael A Grandner, PhD

Role: primary

Chloe CA Wills

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37141002 (View on PubMed)

Other Identifiers

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2012256803

Identifier Type: -

Identifier Source: org_study_id