Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kunasan Inc.
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Sleep Architecture
研究概览
简要总结
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on the bed - on multiple sleep outcomes in an 8-week randomized crossover study, and to calculate the effect sizes of the intervention to inform power and sample size for future studies.
详细描述
This research is a small, 8wk clinical trial testing the potential effects of an investigational device, Frequen-ZZZ Sleep Pad, on the sleep of adults 40-65 years old. The investigators aim to determine whether sleeping with the Sleep Pad, which creates a radio-frequency field around the sleeper, improves sleep. Sleep will be primarily measured using a noninvasive clinical standard method, called polysomnography (PSG), for 6 separate nights in the personal residence of participants. Sleep will also be measured both day and night with a watch-like device that measures activity, and with surveys. The investigators will look for changes in sleep quality, in sleep duration, and in the way that sleep is organized by the body ("sleep architecture"). There are 12-15 in-person appointments across the course of the study. With the data, the investigators hope to also evaluate the feasibility and effect sizes of this non-pharmacological intervention to inform future research, and plan to use data in support of a future FDA application for the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study is a double-blind trial, in which bedside controllers for Sleep Pad systems are coded and either "activated" or "deactivated" (sham/control) by the manufacturer prior to receipt for use in the research. A "deactivated" Sleep Pad bedside controller retains all functionality (and evidence of functionality) of an "activated" bedside controller Sleep Pad, excepting the stimulation. The blind is maintained by a designated study team member who will have access to the list linking device code IDs to their relative active/sham group, and who does not have interaction with study participants. This blind will be lifted if relevant for safety reasons in cases of serious adverse event on a participant case-by-case basis, and on the whole for other researchers after completion of the entire trial for interpretation of analyses.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Diagnosed with a sleep disorder (by self-report)
- •Has an implanted medical device (e.g., pacemaker, cochlear; 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)
- •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)
- •Pregnant, breast-feeding, or planning to become pregnant during the study participation period (by self-report)
- •History of negative reaction to acupuncture (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)
- •History of sensitivity to, or considers oneself to be uniquely sensitive to, radio-frequency (by self-report)
- •Was previously engaged in this research as a randomized participant
- •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
结局指标
主要结局
Change in Sleep Architecture
时间窗: The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage percentage (relative to Latency to Persistent Sleep, Edinger et al. 2013).
Percentage of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week.
Change in Insomnia Symptoms
时间窗: Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8).
Self-reported score on the Insomnia Severity Index (ISI; 0-28) e-survey, where a higher score indicates worse/more Insomnia symptoms.
次要结局
未报告次要终点