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Behavioural Intervention
Sleepgift Blanket for Sleep Issues
Phase < 1
Recruiting
Led By Zahra Moussavi, Ph.D.
Research Sponsored by University of Manitoba
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 through study completion, 2 years approximately
Awards & highlights
Study Summary
This trial is investigating whether or not a commercially available EMF-blocking blanket called Sleepgift can help improve sleep quality and well-being in adults. The study will be conducted as a placebo-controlled, single-blind cross-over study, meaning that participants will use the Sleepgift blanket for 10 days and then a regular blanket for 10 days, and they will not know which is which. Data on sleep quality and vital signals will be collected and analyzed to see if there is a significant difference between the two.
Who is the study for?
Adults aged between 18 and 70 who are generally healthy, both mentally and physically, can join this study. They must be fluent in English but not currently using regular painkillers, sleeping pills or depression medication. Those with substance abuse issues or participating in another therapeutic study cannot take part.Check my eligibility
What is being tested?
The trial is testing the Sleepgift blanket's ability to block EMF and improve sleep quality and heart health against a sham (fake) blanket. Participants will use each blanket for a period of time without knowing which one is real in a cross-over design with a one-month break in between.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like blankets, there aren't any direct side effects expected from the product itself. However, monitoring during sleep will occur to ensure participant safety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, 2 years approximately
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 2 years approximately
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep quality measure
Secondary outcome measures
heart rate variability
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active EMF blanketActive Control2 Interventions
participants will receive the real EMF blocker blanket
Group II: Sham EMF blanketPlacebo Group2 Interventions
participants will receive the sham EMF blocker blanket
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,496 Total Patients Enrolled
1 Trials studying Sleep
26 Patients Enrolled for Sleep
BB HolisticsUNKNOWN
Zahra Moussavi, Ph.D.Principal InvestigatorUniversity of Manitoba
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I have been diagnosed with a major neurological or mood disorder.I regularly take medication for pain, sleep, or depression.I am between 18 and 70 years old.I am in good mental and emotional health.I cannot communicate well in English.
Research Study Groups:
This trial has the following groups:- Group 1: Active EMF blanket
- Group 2: Sham EMF blanket
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.
Sleep Patient Testimony for trial: Trial Name: NCT05463302 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged fifty or over admissible for the research study?
"This medical trial is seeking patients aged between 18 and 70. There are 31 trials for minors, and 87 studies that target geriatric populations."
Answered by AI
Are recruitments still occurring for this trial?
"According to the clinicaltrials.gov listing, this medical trial is no longer recruiting participants having initially been posted on September 1st 2022 and updated for the last time on July 14th 2022. Currently, 143 other trials are actively enrolling patients though."
Answered by AI
Is my profile compatible with the criteria of this research project?
"This clinical trial is currently seeking 30 sleep-deprived individuals aged 18 to 70. In order to qualify, patients must be cognitively and psychologically sound as well as able to comprehend English proficiently."
Answered by AI
Who else is applying?
What state do they live in?
Manitoba
Tennessee
Pennsylvania
Other
What site did they apply to?
Riverview Health Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
I've had insomnia for 20+ years. Have tried 4 different medications with only moderate improvement.
PatientReceived 1 prior treatment
I have tried 3 sleep medications, meditation and camomile tea . I still don’t fall asleep or stay asleep very well.
PatientReceived 2+ prior treatments
The joy of being almost 50! I used to be a great sleeper. Now? Not so much. I have a tough time falling asleep and staying asleep. Sleep medications make me groggy in the morning, so I'm looking for alternative methods to help me get my sleep back on track.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Riverview Health Center: < 48 hours
Average response time
- < 2 Days
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