- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07746011
A Clinical Trial to Evaluate the Effects of EMF Protection Devices on Sleep and Energy Levels
This study evaluates the effects of a selection of EMF protection devices (Home Harmonizers, Better ZZZs, iCell Chip, Car Harmonizer, Laptop Chip, XL Band, and Device Chips) on sleep quality, sleep quantity, and energy levels in adults aged 30-60 who currently experience sleep difficulties. The trial is a single-arm, unblinded, virtual study conducted over 4 weeks and 4 days (including a 4-day calibration period).
Twenty-four participants will use all test products daily and complete self-reported questionnaires at Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4. Objective sleep data will be collected via an Oura Generation 3 ring worn throughout the study. Secondary outcomes include participants' perceptions of effects on sleep, energy, focus, and general well-being.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Nevada
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Las Vegas, Nevada, 미국, 89118
- Citruslabs
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Be male or female
- Be aged 30-60
- Anyone currently experiencing issues regarding any of the following: sleeping, falling asleep, staying asleep, or failing to feel refreshed after sleep
- Must have all of the following items: bed with a foam or spring mattress, a car with a single cigarette lighter, iPhone 12, 13, 14, 15, or 16, laptop, and Wi-Fi router
- Must have at least two of the following: Wi-Fi extender, smart TV, personal computer, ceiling fan in the bedroom, air purifier
- Must have access to where the electricity enters the home, such as an electric (smart) meter outside, the pipe closest to the electric meter, or the fuse box inside the home
- If taking any products, medications, or supplements that target sleep and/or energy during the test period, has been doing so consistently for three months, and is willing to maintain this routine for the duration of the study
- Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study
- Must be able to sleep at home consistently and must not plan to travel for business, vacation, or any other reason during the study period
- Anyone who lives in a single-family residence (i.e., no apartments, condos, or mobile homes)
- Willing to stop using a cellphone watch for the duration of the study
- Must be willing to wear a wristband all day, shaped much like a cellphone watch, and to remove it at night while sleeping
- Willing to remove any other fitness tracking or sleep tracking devices during the study, such as Fitbits, Garmin, and Whoop products
- Must be willing to wear an Oura Ring 24 hours per day during the duration of the study
- Resides in the United States
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, such as cancer, auto-immune conditions, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period
- Sleeps on any of the following beds: adjustable beds, beds equipped with grounding mats, or any bed that connects to an electrical outlet
- Anyone with a sleep-related condition or disorder
- Anyone who is pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men)
- Anyone who lives within 50 miles of a military base or one block of XL powerlines or a cell tower
- Anyone who lives in a rural/country home
- Anyone unwilling to follow the study protocol
- Currently partaking in another research study and will not be partaking in any other research study for the next four weeks or at any point during this study's duration
- Anyone who has Starlink internet or fiber-optic internet
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: EMF Protection Devices
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All participants receive and use all test products simultaneously: 2 Home Harmonizers, 1 Better ZZZs pad (placed under mattress), 1 iCell Chip (for iPhone 12-16), 1 Car Harmonizer (inserted into car cigarette lighter), 1 Laptop Chip, 1 XL Band (worn on wrist during waking hours), and 8 Device Chips (placed on household EMF-emitting devices).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in objective sleep quality
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Assessed using Oura Generation 3 ring sleep metrics.
Change from baseline will be evaluated at each subsequent assessment.
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Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Self-Reported Sleep
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Assessed using validated sleep questionnaire total score(s).
Change from baseline will be evaluated at each subsequent assessment.
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Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Change in Self-Reported Energy Levels
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Assessed via self-reported questionnaire measuring participants' perceptions of the product's effects on energy levels
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Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
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Change in Self-Reported Focus
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Assessed via self-reported questionnaire measuring participants' perceptions of the product's effects on focus
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
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Change in Self-Reported Calmness
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Assessed via self-reported questionnaire measuring participants' perceptions of the product's effects on calmness
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Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Change in Self-Reported General Well-Being
기간: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
Assessed via self-reported questionnaire measuring participants' perceptions of the product's effects on general well-being
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20760
- legacy-20760
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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