Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

N/ACompletedNCT03072017

University of Pennsylvania20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

MBATBEHAVIORAL

Breathing-based intervention

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Sleep onset latency

Time to fall asleep

Time frame: two weeks

Data from ClinicalTrials.gov

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