Frequen-ZZZ SleepPad Investigational Device POC

Ki vehet részt

• Written informed consent is obtained from the subject
• Subject is an English speaker and reader. They are able to understand the procedures related to the study
• Subject is 40-65 years of age at enrollment (by self report at Screening \& verified with photo ID at full Consent)
• Subject is not engaged in rotating or nocturnal shift employment (by self-report at Screening)
• Subject is living independently (by self-report and/or according to their status at a community living facility)
• Subject's personal residence is equipped with functional WiFi and subject is willing to permit study device connection to their WiFi (by self-report at Screening)
• Insomnia Severity Index score of ≥8 at enrollment (based on self-administration at screening)
• Willing to refrain from initiating new, sleep-directed interventions (e.g. medication; behavioral) that are not a part of this study protocol for the duration of study participation (by self-report)
• Willing to refrain from all nicotine use for the duration of participation (by self-report)
• Willing to refrain from pet access to the bed or sleeping space for the duration of participation (by self-report)
• Regularly sleeping on a non-water bed (by self-report)
• Has and uses own smart phone or tablet device, and is willing to continue to use personal device daily for study purposes (by self-report)

Ki nem vehet részt

• Taking any physician-directed pharmacologic intervention for sleep or actively engaged in a clinically-validated course of therapy (including behavioral therapy for sleep; by self-report)
• Diagnosed hydration problems or taking prescribed diuretic medication (by self-report)
• Was previously engaged in this research as a randomized participant
• Diagnosed with a sleep disorder (by self-report)
• Diagnosed serious mental/neurologic health disorder or substance use disorder (e.g., autism, psychosis, depression/bipolar, dementia; by self-report)
• Personal health history of epilepsy or traumatic brain injury (by self-report)
• History of negative reaction to acupuncture (by self-report)
• History of sensitivity to, or considers oneself to be uniquely sensitive to, radio-frequency (by self-report)
• Has an implanted medical device (e.g., pacemaker, cochlear; by self-report)
• Pregnant, breast-feeding, or planning to become pregnant during the study participation period (by self-report)
• Recreational use of illicit substances in the past month (by self-report)
• Any nicotine use in the past 3 months (by self-report)
• If a participant does not live within a reasonable commutable distance from the Penn State University - University Park campus (i.e. ~20min) to accommodate off-site study visits, then they must be willing to accept the costs and responsibilities of coming to campus (15-17 visits) in order to participate