Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

Insomnia Clinical Trial

— MBAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072017
• Other study ID #: 816717
• Status: Completed
• Phase: N/A
• First received: February 27, 2017
• Last updated: July 13, 2017
• Start date: July 1, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• MBAT
Breathing-based intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Advanced Medical Electronics, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep onset latency	Time to fall asleep	two weeks