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

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: MBAT

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBAT; Monitored breathing awareness therapy administered using a mobile device on a nightly basis during sleep onset.	Behavioral: MBAT; Breathing-based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep onset latency	Time to fall asleep	two weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Advanced Medical Electronics

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 816717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: At conclusion of study as per NIH guidelines

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No