Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2
MBAT-2
1 other identifier
interventional
112
1 country
1
Brief Summary
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 8, 2024
February 1, 2024
2.9 years
June 12, 2017
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep onset latency
time to fall asleep
four weeks
Study Arms (2)
Sleep education and relaxation 1
ACTIVE COMPARATORBehavioral education intervention about sleep and relaxation
Sleep education and relaxation 2
EXPERIMENTALBehavioral education intervention about sleep and relaxation
Interventions
Sleep hygiene and relaxation training; Sleep education and relaxation 1
Modified sleep hygiene and relaxation training; Sleep education and relaxation 2
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nalaka Gooneratnelead
- Advanced Medical Electronicscollaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 14, 2017
Study Start
June 20, 2019
Primary Completion
May 31, 2022
Study Completion
December 31, 2025
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
At conclusion of study as per NIH guidelines