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NCT03187340 Clinical Trial

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2

Insomnia Clinical Trial

— MBAT-2  

Official title:
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03187340
Other study ID # 10053582
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 112
Est. completion date December 31, 2025
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
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).

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep education and relaxation 1
Sleep hygiene and relaxation training; Sleep education and relaxation 1
• Sleep education and relaxation 2
Modified sleep hygiene and relaxation training; Sleep education and relaxation 2

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Nalaka Gooneratne Advanced Medical Electronics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep onset latency time to fall asleep four weeks
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