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

• Sponsor: Nalaka Gooneratne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03187340
• Collaborator: Advanced Medical Electronics (Other)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.4
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Sleep education and relaxation 1; Behavioral: Sleep education and relaxation 2	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study
• Actual Study Start Date: Jun 20, 2019
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sleep education and relaxation 1 Behavioral education intervention about sleep and relaxation	Behavioral: Sleep education and relaxation 1; Sleep hygiene and relaxation training; Sleep education and relaxation 1
Experimental: Sleep education and relaxation 2 Behavioral education intervention about sleep and relaxation	Behavioral: Sleep education and relaxation 2; Modified sleep hygiene and relaxation training; Sleep education and relaxation 2

Outcome Measures

Primary Outcome Measures

1. Sleep onset latency [four weeks]

   time to fall asleep

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• Nalaka Gooneratne
• Advanced Medical Electronics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nalaka Gooneratne, Associate Professor, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03187340
• Other Study ID Numbers: 10053582
• First Posted: Jun 14, 2017
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jul 28, 2020