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Procedure

Single Arm for Sleep

N/A
Recruiting
Research Sponsored by Gerrish MedEsthetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 22 to 70 years of age
Subject scored a 2 or higher on PHQ-9 sleep related question (#3), OR subject scored 2 or more on at least 2 QIDS-SR sleep related questions (#'s 1-4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up various - over 8 weeks
Awards & highlights

Study Summary

This trial aims to see how a type of magnetic therapy called Repetitive Transcranial Magnetic Stimulation (rTMS) affects sleep quality, mood, and memory.

Who is the study for?
This trial is for adults aged 22-70 who are generally healthy and experiencing poor sleep quality. Women must not be pregnant or breastfeeding and use birth control if of childbearing potential. Participants should have stable doses of any psychiatric or sleep meds for two weeks before the trial.Check my eligibility
What is being tested?
The study tests Repetitive Transcranial Magnetic Stimulation (rTMS) to see if it can improve sleep, mood, and memory in participants. It's a pilot study, which means it's an early-stage trial to gather initial data on the effects of rTMS.See study design
What are the potential side effects?
Possible side effects include headaches, scalp discomfort at the stimulation site, lightheadedness, brief twitching of facial muscles during treatment, or seizures (though very rare).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 70 years old.
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I have trouble sleeping, as shown by my scores on depression or sleep questionnaires.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~various - over 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and various - over 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Quality - Jenkins Sleep Scale
Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)
Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)
Secondary outcome measures
Memory - RAVLT Delayed Recall
Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)
Mood - PANAS (Positive and Negative Affect Schedule)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Gerrish MedEstheticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary objectives of this medical study?

"The primary endpoint of this trial is to evaluate sleep quality using the PHQ-9 scale over an 8-week period. Additionally, secondary outcomes include assessing mood using SAMMS (consisting of 8 questions with a total score range of 0-80, where higher scores indicate better mood), VAMS (comprised of 7 questions with a total score range of 0-70, where higher scores represent improved mood), and memory by measuring RAVLT Delayed Recall as an indicator for forgetting (calculated by subtracting the score from Trial 5 from the delayed recall score)."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Indeed, clinicaltrials.gov states that this trial is currently seeking individuals to participate. The initial posting date for the trial was November 7th, 2023, and it underwent its most recent revision on January 16th, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The study was initially posted on November 7th, 2023 and underwent its most recent update on January 16th, 2024. A total of 30 individuals are being sought at a single research site."

Answered by AI

Are individuals who are 70 years of age or older eligible to participate in this clinical trial?

"Eligible individuals for this clinical trial must be at least 22 years of age and no older than 70 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
rTMS for Neuroenhancement
2023. "rTMS for Neuroenhancement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06214871.
~16 spots leftby Nov 2024
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