Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-03-01
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sleep Only Group
Participants in this group will wear the DREEM 2 headband for 12 weeks.
DREEM 2 Headband
Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).
Exercise Only Group
Participants in this group will workout twice a week for 12 weeks.
Exercise Routine
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Exercise and Sleep Group
Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.
DREEM 2 Headband
Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).
Exercise Routine
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Interventions
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DREEM 2 Headband
Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).
Exercise Routine
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Eligibility Criteria
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Inclusion Criteria
2. Able to wear DREEM 2 Headband
3. Able to wear a Fitbit wrist watch
4. Able to perform the Everlywell biomarker procedure
5. Able to Understand and Speak English
6. Able to operate a digital device like mobile phone, iPad, or computer
7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
8. Only participants cognitively able and willing to provide consent will be included.
Exclusion Criteria
2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
3. Unable to speak or understand English
4. Unable to use mobile device/smartphone technology
5. Unable or unwilling to consent for any reason.
45 Years
80 Years
ALL
No
Sponsors
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Shipley Foundation
UNKNOWN
Dreem
INDUSTRY
University of Miami
OTHER
Responsible Party
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Azizi Seixas
Associate Professor
Principal Investigators
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Azizi A Seixas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Hospitals
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-01023
Identifier Type: OTHER
Identifier Source: secondary_id
20220931
Identifier Type: -
Identifier Source: org_study_id
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