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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in score between baseline (week 1) and each study condition (weeks 4 & 8, in randomized order)
Awards & highlights
Study Summary
This trial will investigate whether a bed device that generates a low-level electromagnetic field can improve sleep outcomes over 8 weeks.
Who is the study for?
This trial is for adults aged 40-65 with insomnia, who speak and read English, live independently with WiFi, don't work night shifts, aren't pregnant or breastfeeding, have no sleep disorders or implanted medical devices. Participants must not start new sleep treatments or use nicotine during the study.Check my eligibility
What is being tested?
The Frequen-ZZZ SleepPad system's effects on sleep are being tested over an 8-week period. This device generates a low-level electromagnetic field to improve sleep quality. The study uses a randomized crossover design to compare active versus inactive pads.See study design
What are the potential side effects?
Since this is a noninvasive device generating low-level electromagnetic fields, side effects may be minimal but could include discomfort from sleeping on the pad or potential sensitivity to the electromagnetic field.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in score between baseline (week 1) and each study condition (weeks 4 & 8, in randomized order)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in score between baseline (week 1) and each study condition (weeks 4 & 8, in randomized order)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Insomnia Symptoms
Change in Sleep Architecture
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Activated Sleep Pad controllerExperimental Treatment1 Intervention
Treatment dosing is under participant control, by physical proximity/orientation to the Sleep Pad pad portion of the Sleep Pad system, and by a manually operated power button on an activated bedside controller portion of the Sleep Pad system. Dosing is pre-set at a stable level across all participants. Dosing occurs throughout a participant's typical nocturnal sleep period, nightly, unless manually paused by the participant.
Group II: Deactivated Sleep Pad controllerPlacebo Group1 Intervention
Use of the Sleep Pad system is consistent with the Experimental arm, excepting that a deactivated bedside controller portion of the Sleep Pad system is used.
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Who is running the clinical trial?
Kunasan Inc.Lead Sponsor
Penn State UniversityOTHER
355 Previous Clinical Trials
125,747 Total Patients Enrolled
3 Trials studying Sleep
389 Patients Enrolled for Sleep
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had epilepsy or a traumatic brain injury.I can speak and read English and understand study procedures.I have been diagnosed with hydration issues or am on water pills.I am currently taking medication or undergoing therapy for sleep issues as directed by a doctor.I have been diagnosed with a sleep disorder.I agree not to start any new sleep treatments not in the study while participating.I am between 40 and 65 years old.I use my own smartphone or tablet daily and am willing to use it for the study.I live independently.
Research Study Groups:
This trial has the following groups:- Group 1: Activated Sleep Pad controller
- Group 2: Deactivated Sleep Pad controller
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for additional participants in this research effort?
"According to clinicaltrials.gov, the current recruitment status of this medical trial is inactive; it was initially posted on June 15th 2023 and last updated on June 9th 2023. Nevertheless, there are 397 other trials open for enrollment at present."
Answered by AI
Are seniors over the age of seventy-five being enrolled as participants in this investigation?
"This clinical trial's enrollment guidelines stipulate that participants must lie between 40 and 65 years of age."
Answered by AI
Am I eligible to enroll in this research program?
"This clinical trial seeks 10 individuals aged between 40 and 65 with insomnia. Successful applicants will be accepted to participate in the study."
Answered by AI
Who else is applying?
What site did they apply to?
The Pennsylvania State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been on many different medications that either don't work or have side effects. I am desperate to find a treatment other than taking medication.
PatientReceived 2+ prior treatments
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