Multi-center Trial to Improve Nocturia and Sleep in Older Adults (NCT06110091) | Clinical Trial Compass
RecruitingNot Applicable
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
United States192 participantsStarted 2023-12-05
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chron…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.