Skip to content

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03072017
Acronym
MBAT
Enrollment
20
Registered
2017-03-07
Start date
2016-07-01
Completion date
2017-04-30
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

BEHAVIORALMBAT

Breathing-based intervention

Sponsors

Advanced Medical Electronics
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Sleep onset latencytwo weeksTime to fall asleep

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026