- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89118
- Citruslabs
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: EMF Protection Devices
|
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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in objective sleep quality
Lasso di tempo: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
Assessed using Oura Generation 3 ring sleep metrics.
Change from baseline will be evaluated at each subsequent assessment.
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Self-Reported Sleep
Lasso di tempo: Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
Assessed using validated sleep questionnaire total score(s).
Change from baseline will be evaluated at each subsequent assessment.
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Energy Levels
Lasso di tempo: 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 energy levels
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Focus
Lasso di tempo: 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 focus
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported Calmness
Lasso di tempo: 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 calmness
|
Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4
|
|
Change in Self-Reported General Well-Being
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 20760
- legacy-20760
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .