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

Not Applicable

Active, not recruiting

• Conditions: Insomnia
• Interventions: Behavioral: Sleep education and relaxation 2; Behavioral: Sleep education and relaxation 1

• Registration Number: NCT03187340
• Lead Sponsor: Nalaka Gooneratne

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2019-06-20
• Primary Completion: 2022-05-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep education and relaxation 2	Sleep education and relaxation 2	Behavioral education intervention about sleep and relaxation
Sleep education and relaxation 1	Sleep education and relaxation 1	Behavioral education intervention about sleep and relaxation

Primary Outcome Measures

Name	Time	Method
Sleep onset latency	four weeks	time to fall asleep

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States