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治験 NCT06579963 (REFLECT)(対象:心拍数、All-day Steps、Distance Walked、Active Minutes、Moderate-intensity Activity Minutes、Vigorous-intensity Activity Duration、Sleep Quantity、Time in Sleep Stages、Awake Duration、Sleep Score)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Assessing the Effect of Cool Roofs on Health Using Smartwatches (REFLECT)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06579963 (REFLECT) は 介入研究 臨床試験 で、心拍数、All-day Steps、Distance Walked、Active Minutes、Moderate-intensity Activity Minutes、Vigorous-intensity Activity Duration、Sleep Quantity、Time in Sleep Stages、Awake Duration、Sleep Score に関するものです。現在は 募集中 で、2024年9月4日 から開始しています。800 名の参加者 の募集が計画されています。この治験は Aditi Bunker によって主催され、2026年1月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年12月10日 です。
概要
Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are susceptible to increased heat exposure.

Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof application may improve heart health, sleep and physical activity in household occupants.

The long-term research goal is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will use smartwatches to measure the effects cool roof application on heart health, sleep and physical activity in four urban climate hotspots: Ouagadougou, Burkina Faso; Hermosillo, Mexico; Ahmedabad, India; and Niue, Oceania.

詳細説明
Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide - particularly in low resource settings. June 2024 was the 13th consecutive hottest month on record globally - shattering previous records. Heat exposure can instigate and worsen numerous health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, evidence is currently lacking on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce indoor heat stress in low resource settings.

Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. Continuous monitoring of health and wellbeing using smartwatches can provide insight into important parameters such as heart rate, sleep and physical activity - which are all affected by heat. Using smartwatches, the investigators will also continuously measure health and wellbeing outcomes during the day and night. The investigators will conduct a global multi-centre study to investigate the effects of cool-roof use on heart rate, sleep and physical activity in four urban climate hotspots - Ouagadougou, Burkina Faso (sub-Saharan Africa), Ahmedabad, India (Asia), Niue (Oceania), and Sonora, Mexico (Latin America). These sites represent hotspots where people experience a triple burden from heat exposure, chronic health issues and vulnerable housing conditions (slums, informal settlements and low socioeconomic housing). They also exhibit diversity in climate profiles, housing typology, level of socioeconomic development, population density and rates of urbanisation.

This trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in four locations. Findings will inform global policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change.

公式タイトル

A Randomized Controlled Trial (RCT) Evaluating the Effects of Cool Roofs on Health Outcomes Using Smartwatches: a Global Multi-center Study

疾患/病気
心拍数All-day StepsDistance WalkedActive MinutesModerate-intensity Activity MinutesVigorous-intensity Activity DurationSleep QuantityTime in Sleep StagesAwake DurationSleep Score
その他の研究識別子
  • REFLECT
  • 3728163
  • 226745/Z/22/Z (その他の助成金/資金番号) (Wellcome Trust UK)
NCT番号
開始日
2024-09-04
最終更新日
2024-12-10
終了予定日
2026-01-31
目標参加者数
800
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Hot Temperature
Humidity
Housing
Wearable
Smartwatch
Heart rate
Cardiovascular
Physical activity
Sleep
Cool roof
Heat stress
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群(アーム)/介入
参加グループ/群介入/治療法
実験的Cool roof
Households will receive sunlight reflecting 'cool roof' coating on their roofs.
Cool Roof
Cool roofs are a sunlight reflecting roof coating that can reduce indoor temperature. Cool roofs have high solar reflectance (reflecting the ultraviolet and visible wavelengths of sunlight, reducing heat transfer to the surface of a roof) and high thermal emittance (radiating absorbed solar energy).
非介入No cool roof
No cool roof application. Households will keep their original roofing for the duration of the trial.
該当なし
主要評価項目
評価指標指標の説明時間枠
Heart rate
Heart rate in beats per minute measured at 15-second intervals using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
副次評価項目
評価指標指標の説明時間枠
All-day steps
The number of steps measured daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Active minutes
The total number of minutes of active exercise daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Distance walked
The total distance walked daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Moderate-intensity activity minutes
The total number of minutes of moderate-intensity activity daily using Garmin Vivosmart 5 devices.
MeasuSmartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at barements will be taken continuously for 12 months. Participants will be asked to wear their smartwatch for at least two weeks every month.
Vigorous-intensity activity duration
The total number of minutes of vigorous-intensity activity daily using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep quantity
The number of hours spent asleep each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Time in sleep stages
The number of hours spent in sleep stages each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Awake duration
The number of hours spent awake during sleep time each night using Garmin Vivosmart 5 devices.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
Sleep score
The Garmin sleep score (0-100) each night using Garmin Vivosmart 5 devices. A higher score means a better outcome.
Smartwatches will be worn for two consecutive weeks per month. Eight measurement points will be taken: one at baseline and seven over 12 months, covering three consecutive hottest months and four alternate months.
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • Permanent household resident

  • Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.
  • Participant unable to provide written/verbal informed consent. Participants will be excluded if they are not willing or able to wear a smartwatch.
  • In Mexico and Niue, participants will be excluded if they do not have a smartphone with an internet connection that can connect to the smartwatch.
  • Only one participant per household.
Aditi Bunker logoAditi Bunker
  • 🏢Sika Services AG
  • 🏛️SOPREMA
  • 🏢Engineered Polymer Solutions (EPS B.V.)
  • 🏛️Resene
  • 🏛️Pacific Community
  • 🏛️Habitat for Humanity
  • 🧬The Tindall Foundation
  • 🧪Labfront
  • 🏛️Instituto Tecnológico de Hermosillo
  • 🎓University of Ouagadougou, Burkina Faso
  • ⚕️Indian Institute of Public Health, India
  • ⚕️London School of Hygiene and Tropical Medicine
もっと見る
責任者
Aditi Bunker, 治験依頼者・主任研究者, Co-Principal Investigator, University of Auckland, New Zealand
試験中央連絡先
連絡先: Aditi Bunker, Dr, +49 6221 565344, [email protected]
連絡先: Collin Tukuitonga, Sir. Dr., +6493737599, [email protected]
4 4カ国の場所
University Joseph Ki-Zerbo, Ouagadougou, Burkina Faso
Abdramane Soura, 連絡先, +22670026232, [email protected]
Abdramane Soura, 研究責任者
募集未定

Gandhinagar

Indian Institute of Public Health Gandhinagar, Ahmedabad, Gandhinagar, India
Anish Sinha, 連絡先, +919377470505, [email protected]
Dileep Mavlankar, 研究責任者
Anish Sinha, 副研究者
募集中

Sanora

Instituto Tecnológico de Hermosillo, Hermosillo, Sanora, Mexico
Jose Antonio Hoyo Montano, 連絡先, +526621610612, [email protected]
Jose Antonio Hoyo Montano, 研究責任者
募集未定
Niue, Alofi, Niue
Noah Bunkley, 連絡先, +640273502516, [email protected]
連絡先, [email protected]
Collin Tukuitonga, 研究責任者
Noah Bunkley, 副研究者
募集中