Clinical trial NCT06110091: Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Official title: Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nocturia
Insomnia
Lead sponsor: Atlanta VA Medical Center
Sponsor class: FED
Collaborators: name: VA Greater Los Angeles Healthcare System
name: Emory University
name: University of California, Los Angeles
name: University of California, San Francisco
name: University of Alabama at Birmingham
First posted: 2023-10-31
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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. While prior research suggests the benefits of multicomponent behavioral treatment, there is an urgent need for treatment strategies that also address concomitant sleep factors, and this study has the potential to provide evidence needed for this shift in the recommended treatment of nocturia among older adults. The study population includes men and women aged 60 years or older who have nocturia at least twice nightly based on the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) questionnaire and insomnia symptoms based on the Insomnia Severity Index. Participants will be identified through 5 sources: 1) Computer-based screening using the Veterans Affairs (VA) Corporate Database Warehouse to screen veterans who live close to the Medical Center, as well as data pulling real Social Security Numbers (SSNs) from VA's Information and Computing Infrastructure (VINCI); 2) a survey mailed once at the end of year 1 to individuals aged \> 60 years who have received care at VA Greater Los Angeles (VAGLA) and University of California, Los Angeles (UCLA) sleep center and clinics and Atlanta VA and Emory University sleep center and clinics within the past 6 months; 3) referrals from clinic providers; 4) flyers/advertisements posted in the medical centers; and 5) social media advertisements.

Individuals who meet initial screening criteria will be invited to a face-to-face appointment, where participants will provide written informed consent (either paper or e-consent). At the initial screening appointment, participants will be screened for sleep apnea; have their medical records reviewed; be administered questionnaires; have blood and urine tests; and be provided with a wrist actigraph to wear at home for 1 week, along with a sleep and urinary symptom diary to complete while wearing the actigraph. If eligible, participants will be randomly assigned to either the intervention or the control. Participants assigned to Integrated Behavioral Therapy will receive combined cognitive behavioral therapy for insomnia and nocturia delivered by an interventionist, while those assigned to the Health Education Program will be provided with a health education curriculum delivered by the interventionist. After the final session, participants will have a post-intervention assessment and monthly phone calls until the final assessment 4 months later. The post-intervention assessment and 4-month assessment will include many of the same measures from the screening/baseline visit. Overall, participants in either group will receive 2 baseline/screening visits, 5 weekly one hour sessions either in-person or remotely, one post-intervention session, 3 monthly 15-minute phone calls, and 1 final assessment over the span of approximately 4 months.

Our intended sample size is 96 participants in each group across all sites (total of N=192 randomized participants across all sites; n=96 at Atlanta VA, with n=48 randomized to the Integrated Behavioral Therapy and n=48 randomized to the Health Education Program. The investigators expect to complete 392 baseline assessments (196 per site) to reach our intended sample size.

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 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

Primary outcomes:
measure: Mean Nocturia Frequency
timeFrame: 4 months
Secondary outcomes:
measure: Self-Reported Insomnia Severity Index
timeFrame: 4 months
measure: Nocturia-Quality of Life
timeFrame: 4 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Atlanta
country: United States
facility: Atlanta VAHCS
state: Georgia
Study officials:
affiliation: Atlanta VAMC & Emory University
name: E. Camille Vaughan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: