ClinicalTrials.Veeva

Menu

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

N

Nalaka Gooneratne

Status

Active, not recruiting

Conditions

Insomnia

Treatments

Behavioral: Sleep education and relaxation 1
Behavioral: Sleep education and relaxation 2

Study type

Interventional

Funder types

Other

Identifiers

NCT03187340
10053582

Details and patient eligibility

About

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

Enrollment

112 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

112 participants in 2 patient groups

Sleep education and relaxation 1
Active Comparator group
Description:
Behavioral education intervention about sleep and relaxation
Treatment:
Behavioral: Sleep education and relaxation 1
Sleep education and relaxation 2
Experimental group
Description:
Behavioral education intervention about sleep and relaxation
Treatment:
Behavioral: Sleep education and relaxation 2

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems