Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Recruiting
N/AInterventional Study
NocturiaInsomnia
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
Atlanta VA Medical Center · Federal
Who this trial is looking for
This trial is looking for older adults who have trouble sleeping and often wake up at night to urinate. Participants will receive treatment aimed at improving both their sleep and nighttime urination.
Are You a Good Fit for This Trial?
Rules you outBipolar disorderSleep-disordered breathingGenitourinary cancerSignificant cognitive impairment
You may be able to join if
I am 60 years or older.
I wake up at least 2 times a night to urinate.
I have trouble sleeping.
I can attend weekly study visits.
You may not be able to join if
I have had cognitive behavioral therapy for insomnia before.
I have bipolar disorder.
I have significant cognitive impairment.
I have another sleep disorder that explains my sleep issues.
I currently have a urinary tract infection.
I have unstable health conditions that could lead to hospitalization.
I have had surgery on my pelvic or colon in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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 c…
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
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