Multi-center Trial to Improve Nocturia and Sleep in Older Adults

Part of paid clinical trials in Los Angeles, California.

Sponsor
Atlanta VA Medical Center
Study ID
NCT06110091
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Integrated Behavioral Therapy Program — BEHAVIORAL
    Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia
  • Health Education Program — BEHAVIORAL
    Health Education Program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment.

Study Details

The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.

Key Dates

Start date
Dec 5, 2023
Status verified
Sep 2025
Primary completion
Apr 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Integrated Behavioral Therapy Program
    Integrated Behavioral Therapy consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. This program integrates cognitive-behavioral treatment for nocturia and insomnia. Brief telephone check-ins will be comprised of review of topics discussed during the sessions.
  • Placebo Comparator: Health Education Program
    The Health Education Program consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. The program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment. Brief telephone check-ins will be comprised of review of health topics discussed during the sessions.

Primary Outcome Measure

Mean Nocturia Frequency [ Time Frame: 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia91343
Erin E Der-Mcleod
[email protected]
818-891-7711
Constance H Fung, MD, MSHS (PRINCIPAL_INVESTIGATOR)
Atlanta VAHCSAtlantaGeorgia30033
E Camille Vaughan, MD, MS
[email protected]
404 315 4100
Taressa Sergent
[email protected]
404 315 4100

Find similar trials in Los Angeles, CA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
VA Greater Los Angeles Healthcare System· Los Angeles, CAAtlanta VAHCS· Atlanta, GA

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