Improving sleep and reducing nighttime urination in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) is a randomized trial designed to evaluate the effectiveness of an integrated treatment approach for older adults suffering from both nocturia and insomnia. This study aims to assess how this combined treatment impacts participants' quality of life. Participants will be recruited from various sources, including veterans' databases and sleep clinics, and will undergo weekly visits to monitor their progress. The trial seeks to provide evidence for a shift in treatment strategies for nocturia in older adults.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• VA Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• Atlanta VAHCS
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: E. Camille Vaughan, MD, MS — Atlanta VAMC & Emory University
• Study coordinator: Taressa Sergent
• Email: Taressa.Sergent@va.gov
• Phone: (404) 315-4100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing nighttime voiding in older women with sleep strategies

  This study tests whether brief behavioral sleep therapy and mindfulness, alone or together, reduce how often older women wake at night to urinate and how much urine they produce at night.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07760779

• SleepCogni for children with chronic insomnia

  A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• Remote ischemic conditioning for post-stroke insomnia

  A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu, Sichuan · NCT07874594

• Nurse-guided app-based brief behavioral therapy for insomnia in older adults

  Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.

  Recruiting Taipei Medical University · Taipei · NCT07842250

• Compare two bladder medicines and placebo for urgency incontinence in older women

  This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07829029

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.