Multi-center Trial to Improve Nocturia and Sleep in Older Adults
MINT
1 other identifier
interventional
192
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
September 30, 2025
September 1, 2025
4.3 years
October 16, 2023
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Nocturia Frequency
The primary outcome of nocturia frequency will be measured as the average episodes per night at baseline, 2 months, and 4 months through the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire. An adapted version that asks the participant to record the number of nocturia episodes if the "4+" nocturia option is selected will be used. A linear mixed effects model will be used to evaluate the group difference over time in average nocturia frequency per night.
4 months
Secondary Outcomes (2)
Self-Reported Insomnia Severity Index
4 months
Nocturia-Quality of Life
4 months
Study Arms (2)
Integrated Behavioral Therapy Program
EXPERIMENTALIntegrated Behavioral Therapy consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. This program integrates cognitive-behavioral treatment for nocturia and insomnia. Brief telephone check-ins will be comprised of review of topics discussed during the sessions.
Health Education Program
PLACEBO COMPARATORThe Health Education Program consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. The program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment. Brief telephone check-ins will be comprised of review of health topics discussed during the sessions.
Interventions
Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia
Health Education Program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlanta VA Medical Centerlead
- VA Greater Los Angeles Healthcare Systemcollaborator
- Emory Universitycollaborator
- University of California, Los Angelescollaborator
- University of California, San Franciscocollaborator
- University of Alabama at Birminghamcollaborator
Study Sites (2)
VA Greater Los Angeles Healthcare System
Los Angeles, California, 91343, United States
Atlanta VAHCS
Atlanta, Georgia, 30033, United States
Related Publications (1)
Fung C, Bolstad CJ, Huang A, Markland A, Cheng J, Alessi C, Johnson TM 2nd, Bliwise DL, Burgio KL, Martin JL, Schembri M, Der-McLeod E, Sergent T, Vaughan C. Protocol for a multi-site randomized trial testing an integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT). Res Sq [Preprint]. 2025 Sep 25:rs.3.rs-7330051. doi: 10.21203/rs.3.rs-7330051/v1.
PMID: 41041560DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E. Camille Vaughan, MD, MS
Atlanta VAMC & Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 31, 2023
Study Start
December 5, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF