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

2021년 11월 1일 업데이트: MICHAEL A GRANDNER, University of Arizona
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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

30

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Active
An active phototherapy device
장치: Phototherapy device
The active phototherapy device will emit light
가짜 비교기: Sham (Placebo)
An inactive device
장치: Phototherapy device
The active phototherapy device will emit light

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in subjective rating of the device across a 3-week intervention
기간: 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 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
기간: 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 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
기간: 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.
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.

2차 결과 측정

결과 측정
측정값 설명
기간
Change in mean sleep latency assessed using sleep diaries
기간: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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).
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
기간: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
The Karolinska Sleepiness Scale (KSS) measures situational sleepiness on a 9-point scale
Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
Circadian Energy Scale (CIRENS) score
기간: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Positive Affect
기간: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Negative Affect
기간: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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.
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
기간: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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".
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
기간: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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.
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
기간: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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).
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
기간: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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).
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
기간: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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).
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
기간: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Arizona

협력자

CeraZ LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 9월 2일

기본 완료 (예상)

2022년 1월 30일

연구 완료 (예상)

2022년 1월 30일

연구 등록 날짜

최초 제출

2021년 11월 1일

QC 기준을 충족하는 최초 제출

2021년 11월 1일

처음 게시됨 (실제)

2021년 11월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 11월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 11월 1일

마지막으로 확인됨

2021년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2012256803

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