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Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

Not Applicable
Completed
Conditions
Insomnia
Registration Number
NCT03072017
Lead Sponsor
University of Pennsylvania
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Sleep onset latencytwo weeks

Time to fall asleep

Secondary Outcome Measures
NameTimeMethod

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