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

University of Pennsylvania

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: MBAT

Study type: Interventional

Funder types: Other

Identifiers

NCT03072017

816717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MBAT

Experimental group

Description:

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

Treatment:

Behavioral: MBAT