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Behavioral Intervention
Sleep Education and Relaxation for Insomnia (MBAT-2 Trial)
N/A
Waitlist Available
Research Sponsored by Nalaka Gooneratne
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 four weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new, non-drug intervention for insomnia that can be used on a mobile device.
Who is the study for?
This trial is for older adults with insomnia, experiencing trouble falling asleep at least three nights a week. Participants must be able to communicate verbally and in written English, have no cognitive impairments or diagnosed non-insomnia sleep disorders like sleep apnea, and must not have upper extremity motor impairments.
What is being tested?
The study tests two types of monitored breathing awareness therapy (MBAT) delivered via mobile devices as a non-drug treatment for insomnia. It aims to see if these therapies can reduce the time it takes to fall asleep and improve overall sleep quality in older adults.
What are the potential side effects?
Since MBAT is a non-drug intervention focusing on education and relaxation techniques, significant side effects are not expected. However, participants may experience varying levels of comfort or effectiveness with the use of mobile devices for therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep onset latency
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep education and relaxation 2Experimental Treatment1 Intervention
Behavioral education intervention about sleep and relaxation
Group II: Sleep education and relaxation 1Active Control1 Intervention
Behavioral education intervention about sleep and relaxation
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Who is running the clinical trial?
Nalaka GooneratneLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Advanced Medical ElectronicsOTHER
5 Previous Clinical Trials
319 Total Patients Enrolled
1 Trials studying Insomnia
20 Patients Enrolled for Insomnia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It takes me over 30 minutes to fall asleep at least 3 nights a week.I do not have any cognitive impairments that would prevent me from following study instructions.I do not have severe arm or hand paralysis that would stop me from participating in MBAT therapy.I have been diagnosed with a sleep disorder other than insomnia.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep education and relaxation 1
- Group 2: Sleep education and relaxation 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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