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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAtlanta VA Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 60 years

Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire

Insomnia Severity Index > 7

Able to attend weekly study visits

Disqualifiers

Prior cognitive behavioral therapy for insomnia

Presence of bipolar disorder

Significant cognitive impairment as measured by a score < 20 on the Mini-Mental State Exam

Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders

Trial design

Treatments tested in this trial

  • Integrated Behavioral Therapy Program
  • Health Education Program

Treatment groups

192 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Atlanta VA Medical Center

Lead sponsor

VA Greater Los Angeles Healthcare System

Collaborator

Emory University

Collaborator

University of California, Los Angeles

Collaborator

University of California, San Francisco

Collaborator

University of Alabama at Birmingham

Collaborator