- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07685262
Morning Bright Light Therapy and Daytime Functioning in University Students (BLIGHT)
Effects of Morning Bright Light Therapy on Sleep, Alertness, Mood, and Cognition in Healthy University Students: A Randomized Crossover Trial
This study tests whether a week of morning bright light therapy changes how well healthy young adults sleep and how alert, positive, and mentally sharp they feel during the day.
Morning light is the body's main signal for keeping its internal clock and sleep-wake timing on track. Many university students keep irregular hours and spend most of the day indoors, where light is far dimmer than daylight. This study asks whether adding a short, bright morning light session can help.
Each participant takes part for two weeks. For one week they use a bright light box for 30 minutes each morning, shortly after waking; for the other week they keep their usual lighting. The order of the two weeks is decided at random, and each person serves as their own comparison.
Throughout both weeks, sleep is tracked with a wrist-worn Fitbit and a short daily diary. Participants also rate their sleepiness and mood, complete brief computer-based attention and memory tasks, and take part in a short interview at the end about their experience.
The study compares the bright-light week with the usual-light week to see whether morning bright light improves sleep regularity and efficiency, reduces daytime sleepiness, lifts mood, or affects thinking performance. The trial is being conducted in waves; a first wave has completed and a second wave is planned, pending additional funding.
연구 개요
상세 설명
Background and rationale: Morning light is the principal entraining signal for the human circadian system, acting through melanopsin-containing intrinsically photosensitive retinal ganglion cells that project to the suprachiasmatic nucleus. University students frequently experience irregular sleep-wake schedules and limited daytime light exposure, particularly in cooling-dominant subtropical buildings where occupants keep blinds drawn. Bright light therapy (BLT) is an established treatment for circadian and affective disorders, but its effects on sleep regularity, daytime alertness, mood, and objective cognition in healthy students are less well characterized. This trial evaluates a brief, self-administered morning BLT regimen using a within-subject crossover design.
Design: Single-center, randomized, within-subject (crossover) trial. Each participant completes two consecutive one-week conditions-morning BLT and usual-light control-in counterbalanced order with no washout period. Allocation to condition order (sequence) is randomized, and each participant serves as their own control; all crossover models include condition, period (week), and sequence terms.
Setting and population: Healthy university students residing in shared student housing in Hong Kong. Eligibility is restricted to generally healthy young adults without a diagnosed sleep disorder; sleep quality is screened (Pittsburgh Sleep Quality Index), and individuals with diagnosed insomnia or other relevant conditions are excluded.
Intervention: During the BLT week, participants self-administer a 30-minute session of 10,000 lux (photopic) bright light approximately 30 minutes after waking, using a standard light therapy lamp positioned per manufacturer guidance. The stimulus is characterized in melanopic units (melanopic equivalent daylight illuminance ≈ 8,989 lux). During the control week, participants maintain their usual indoor lighting and morning routine without the lamp.
Assessments: Sleep is monitored continuously with a wrist-worn Fitbit and a daily diary throughout both weeks. Daytime sleepiness and alertness are rated at fixed times of day (Karolinska and Stanford Sleepiness Scales). Mood and affect are assessed with the Positive and Negative Affect Schedule and the Profile of Mood States. A computer-based cognitive battery (Stroop, Flanker, Corsi block-tapping, verbal span) is administered at the end of each condition week. Post-trial semi-structured interviews capture subjective experience and acceptability.
Outcome structure: A small, a priori primary confirmatory outcome family-defined in the approved study protocol on the basis of hypothesized domains rather than observed effects-covers daytime sleepiness, sleep regularity, positive affect, and cognition; remaining measures are secondary or exploratory. Formal outcome-measure definitions are provided in the Outcome Measures module.
Statistical analysis: Outcomes are analyzed with linear mixed-effects models of the form outcome ~ condition + period + sequence + (1 | participant), estimated by REML with Satterthwaite degrees of freedom. Multiplicity is controlled with Holm correction across the primary outcome family. Paired within-person effect sizes (Cohen's dz) accompany model-based estimates, and sensitivity analyses examine period, sequence, and carryover effects.
Conduct in waves: The trial is being conducted in waves. A first wave (33 participants) has completed data collection; a second wave is planned and will commence pending additional funding, so recruitment is currently inactive.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Cehao Yu, PhD
- 전화번호: +852 3400 3012
- 이메일: cehao.yu@polyu.edu.hk
연구 장소
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Hung Hom, 홍콩
- 모병
- The Hong Kong Polytechnic University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Enrolled university student
- Aged 18 years or older
- Generally healthy, with no diagnosed sleep disorder (sleep quality screened using the Pittsburgh Sleep Quality Index)
- Residing in shared student housing
Exclusion Criteria:
- Diagnosed insomnia or other diagnosed sleep disorder
- Other medical, psychiatric, or neurological condition that could affect sleep, mood, or cognition
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Morning Bright Light Therapy
During this one-week condition, participants self-administer a 30-minute session of 10,000 lux bright light (melanopic equivalent daylight illuminance ≈ 8,989 lux) each morning, approximately 30 minutes after waking, using a standard light therapy lamp positioned per manufacturer guidance.
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Self-administered 30-minute session of 10,000 lux (photopic) bright light each morning, approximately 30 minutes after waking, for one week, using a standard 10,000-lux light therapy lamp positioned per manufacturer guidance.
Stimulus characterized in melanopic units (melanopic equivalent daylight illuminance ≈ 8,989 lux).
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간섭 없음: Usual Light (Control)
During this one-week condition, participants maintain their usual indoor lighting and morning routine without the light therapy lamp.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sleep regularity
기간: Recorded continuously across each 1-week condition (bright-light week and usual-light week).
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Regularity of sleep timing derived from wrist-worn Fitbit actigraphy and a daily sleep diary (e.g., day-to-day variability in sleep onset and offset).
Condition-week values are compared between the bright-light week and the usual-light week.
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Recorded continuously across each 1-week condition (bright-light week and usual-light week).
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Daytime sleepiness (Karolinska Sleepiness Scale)
기간: Assessed daily at fixed times across each 1-week condition (bright-light week and usual-light week).
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Subjective daytime sleepiness rated on the 9-point Karolinska Sleepiness Scale (KSS) at fixed times of day.
Condition-week values are compared between the bright-light week and the usual-light week.
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Assessed daily at fixed times across each 1-week condition (bright-light week and usual-light week).
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Positive affect (PANAS Positive Affect subscale)
기간: End of each 1-week condition (bright-light week and usual-light week).
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Positive affect measured with the Positive and Negative Affect Schedule (PANAS) positive-affect subscale.
Condition-week scores are compared between the bright-light week and the usual-light week.
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End of each 1-week condition (bright-light week and usual-light week).
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Cognitive performance (computer-based battery)
기간: End of each 1-week condition (bright-light week and usual-light week).
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Objective cognitive performance on a computer-based battery (Stroop, Flanker, Corsi block-tapping, and verbal span tasks).
Condition-week performance is compared between the bright-light week and the usual-light week.
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End of each 1-week condition (bright-light week and usual-light week).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HSEARS20240430005
- P0050050 (기타 보조금/기금 번호: University Grants Committee)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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잠에 대한 임상 시험
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Fujian Shengdi Pharmaceutical Co., Ltd.모병Bstructive sleep apnea (OSA) 및 비만중국