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

Primary Purpose

Insomnia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep education and relaxation 1

Sleep education and relaxation 2

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sleep education and relaxation 1

Sleep education and relaxation 2

Arm Description

Behavioral education intervention about sleep and relaxation

Outcomes

Primary Outcome Measures

Sleep onset latency

time to fall asleep

Secondary Outcome Measures

Full Information

NCT ID

NCT03187340

First Posted

June 12, 2017

Last Updated

October 16, 2023

Sponsor

Nalaka Gooneratne

Collaborators

Advanced Medical Electronics

1. Study Identification

Unique Protocol Identification Number

NCT03187340

Brief Title

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

Acronym

MBAT-2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 20, 2019 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nalaka Gooneratne

Collaborators

Advanced Medical Electronics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sleep education and relaxation 1

Arm Type

Active Comparator

Arm Description

Behavioral education intervention about sleep and relaxation

Arm Title

Sleep education and relaxation 2

Arm Type

Experimental

Arm Description

Behavioral education intervention about sleep and relaxation

Intervention Type

Behavioral

Intervention Name(s)

Sleep education and relaxation 1

Intervention Description

Sleep hygiene and relaxation training; Sleep education and relaxation 1

Intervention Type

Behavioral

Intervention Name(s)

Sleep education and relaxation 2

Intervention Description

Modified sleep hygiene and relaxation training; Sleep education and relaxation 2

Primary Outcome Measure Information:

Title

Sleep onset latency

Description

time to fall asleep

Time Frame

four weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

At conclusion of study as per NIH guidelines

Learn more about this trial

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

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