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OpenTrials
Completed

NCT Number: NCT03072017

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

MBAT

Behavioral

Breathing-based intervention

Primary outcomes

  1. Sleep onset latency

    Time frame: two weeks

    Time to fall asleep

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Advanced Medical Electronics

Registry information

Official study title

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot

Acronym: MBAT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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