Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

NCT03072017 | Completed

• 1 other identifier: 816717
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep onset latency

  Time to fall asleep

  two weeks

Study Arms (1)

MBAT

EXPERIMENTAL

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

Behavioral: MBAT

Interventions

MBAT BEHAVIORAL

Breathing-based intervention

MBAT

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Advanced Medical Electronics: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 7, 2017
• Study Start: July 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share