search
Back to results

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults (MBAT)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBAT
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Sleep onset latency > 30 min for at least 3 nights per week

Exclusion Criteria:

  1. Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages).
  2. Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol).
  3. History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder
  4. Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MBAT

    Arm Description

    Monitored breathing awareness therapy administered using a mobile device on a nightly basis during sleep onset.

    Outcomes

    Primary Outcome Measures

    Sleep onset latency
    Time to fall asleep

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2017
    Last Updated
    July 13, 2017
    Sponsor
    University of Pennsylvania
    Collaborators
    Advanced Medical Electronics
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03072017
    Brief Title
    Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults
    Acronym
    MBAT
    Official Title
    Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    April 30, 2017 (Actual)
    Study Completion Date
    April 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    Advanced Medical Electronics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Open-label pilot study in 20 older adults with insomnia (sleep onset latency>30 minutes for at least 3 nights a week) with a two week intervention period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MBAT
    Arm Type
    Experimental
    Arm Description
    Monitored breathing awareness therapy administered using a mobile device on a nightly basis during sleep onset.
    Intervention Type
    Behavioral
    Intervention Name(s)
    MBAT
    Intervention Description
    Breathing-based intervention
    Primary Outcome Measure Information:
    Title
    Sleep onset latency
    Description
    Time to fall asleep
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1) Sleep onset latency > 30 min for at least 3 nights per week Exclusion Criteria: Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    At conclusion of study as per NIH guidelines

    Learn more about this trial

    Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

    We'll reach out to this number within 24 hrs