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

NCT ID: NCT03187340

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sleep education and relaxation 1

Behavioral education intervention about sleep and relaxation

Group Type ACTIVE_COMPARATOR

Sleep education and relaxation 1

Intervention Type BEHAVIORAL

Sleep hygiene and relaxation training; Sleep education and relaxation 1

Sleep education and relaxation 2

Behavioral education intervention about sleep and relaxation

Group Type EXPERIMENTAL

Sleep education and relaxation 2

Intervention Type BEHAVIORAL

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

Interventions

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Sleep education and relaxation 1

Sleep hygiene and relaxation training; Sleep education and relaxation 1

Intervention Type BEHAVIORAL

Sleep education and relaxation 2

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Medical Electronics

OTHER

Sponsor Role collaborator

Nalaka Gooneratne

OTHER

Sponsor Role lead

Responsible Party

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Nalaka Gooneratne

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10053582

Identifier Type: -

Identifier Source: org_study_id

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