Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2 (MBAT-2)

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study

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: Active, not recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep education and relaxation 1; Behavioral: Sleep education and relaxation 2

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep education and relaxation 1; Behavioral education intervention about sleep and relaxation	Behavioral: Sleep education and relaxation 1; Sleep hygiene and relaxation training; Sleep education and relaxation 1
Experimental: Sleep education and relaxation 2; Behavioral education intervention about sleep and relaxation	Behavioral: Sleep education and relaxation 2; Modified sleep hygiene and relaxation training; Sleep education and relaxation 2

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nalaka Gooneratne
• Collaborators: Advanced Medical Electronics

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

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: 10053582

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