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

Description

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.

Conditions

Nocturia, Insomnia

Study Overview

Study Details

Study overview

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.

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

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

Condition
Nocturia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 91343

Atlanta

Atlanta VAHCS, Atlanta, Georgia, United States, 30033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Untreated sleep-disordered breathing (respiratory event index ≥ 15 plus • Epworth Sleepiness Scale \> 10 or respiratory event index \> 30. Note that participants with treated sleep-disordered breathing will not be excluded)
  • * Current urinary tract infection or hematuria
  • * Unstable doses or recent changes in bladder medication
  • * New or recently discontinued insomnia medication within past month
  • * Previous or current intensive behavioral therapy for insomnia or urinary symptoms,
  • * Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by overall study PIs or Site PI.
  • * Unstable medical conditions that could contribute to nocturia or insomnia such as poorly controlled heart failure as evidenced on physical examination, poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 9.0, or chronic kidney disease (stage 4 or 5) or a potential to initiate dialysis in 3 months
  • * Unstable psychiatric conditions (e.g., psychosis, active alcohol/substance abuse based on history and medical records)
  • * Unstable housing situation
  • * Evidence of significant urinary retention as measured by a residual bladder volume of ≥ 200 mL by bladder ultrasound with 15 minutes of voiding
  • * Genitourinary cancer undergoing active treatment
  • * Pelvic or colon surgery within 6 months of enrollment or onabotulinum toxin therapy for urinary symptoms within 6 months of enrollment

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Atlanta VA Medical Center,

E. Camille Vaughan, MD, MS, PRINCIPAL_INVESTIGATOR, Atlanta VAMC & Emory University

Study Record Dates

2028-08