- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Nevada
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Las Vegas, Nevada, Spojené státy, 89118
- Citruslabs
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in objective sleep quality
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Self-Reported Sleep
Časové okno: 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
Časové okno: 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
Časové okno: 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
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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 Calmness
Časové okno: 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
Časové okno: 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 general well-being
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Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 20760
- legacy-20760
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