NocturiaMINTNCT06110091
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
A study testing Integrated Behavioral Therapy Program and Health Education Program in people with Nocturia and Insomnia, run by Atlanta VA Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Integrated Behavioral Therapy Program and Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2023to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atlanta VAHCS
Atlanta, Georgia, 30033
E Camille Vaughan, MD, MS, 404 315 4100 ext. 373100, elizabeth.vaughan2@va.gov
Taressa Sergent, 404 315 4100 ext. 373124, Taressa.Sergent@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 91343
Erin E Der-Mcleod, 818-891-7711 ext. 36067, Erin.Der-mcleod@va.gov
Constance H Fung, MD, MSHS
About this study
Official title: Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)
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.
Read the 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.
- Being tested
- Integrated Behavioral Therapy Program, Health Education Program
- Medical subject headings
- Nocturia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behavioral Therapy ProgramBehavioural
Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia
Health Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Behavioral Therapy Program | Experimental | Integrated 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. Receives: Behavioral: Integrated Behavioral Therapy Program |
| Health Education Program | Placebo comparator | The 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. Receives: Behavioral: Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
Self-Reported Insomnia Severity Index
The self-reported Insomnia Severity Index is a 7-item instrument with high internal consistency and validity for measures of fatigue, quality of life, anxiety, and depression. The total score is the sum of all seven items and ranges from 0-28 with higher scores indicating greater insomnia severity. The Insomnia Severity Index can also be used as a change score that measures perceived severity of insomnia symptoms. A 0.5 standardized mean difference between treatment and control is considered the clinical significance threshold for studies of chronic insomnia disorder.
The Insomnia Severity Index will be modeled similarly with a linear mixed mode. If the distributions of the secondary outcome is skewed and no good transformation is found, the outcome will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models using cumulative logit or generalized logit link for multinomial data.
Measured: 4 months
Nocturia-Quality of Life
The Nocturia-Quality of Life (NQOL) questionnaire provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on persons' lives of nocturia and can be used as an outcome measure to assess impact of different treatment modalities. The NQOL score may be calculated by summing all items, giving a score from 0-58. A greater score indicates a higher impact on QOL.
The NQOL will be modeled similarly with linear mixed models in their original scale or transformed scale as appropriate. If the distributions of the NQOL scores are skewed and no good transformation is found, the outcomes will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models. Similar secondary analyses as those proposed in assessing mean nocturia frequency will be performed on the secondary outcomes NQOL.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start5 Dec 2023
- Primary completionApr 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Greater Los Angeles Healthcare System, Emory University, University of California, Los Angeles, University of California, San Francisco, University of Utah, Birmingham VA Health Care System, Miami VA Healthcare System
- Responsible party
- Principal investigator, Elizabeth Camille Vaughan, Atlanta VA Medical Center
- Investigators
- E. Camille Vaughan, MD, MS, Principal investigator, Atlanta VAMC & Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110091
- Sponsor's protocol ID
- STUDY00006141
- Acronym
- MINT
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Fung CH, Bolstad CJ, Huang A, Markland A, Cheng J, Alessi C, M Johnson T 2nd, Bliwise DL, Martin JL, Burgio KL, Schembri M, Der-McLeod E, Sergent T, Vaughan CP. An integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT): study protocol for a multi-site randomized clinical trial. Trials. 2026 Feb 16;27(1):226. doi: 10.1186/s13063-026-09464-2.
PubMed 41692807Fung 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.
PubMed 41041560
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)
- ClinicalTrials.gov ID
- NCT06110091
- Acronym / sponsor ID
- MINT / STUDY00006141
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Collaborators
- VA Greater Los Angeles Healthcare System, Emory University, University of California, Los Angeles, University of California, San Francisco, University of Utah, Birmingham VA Health Care System, Miami VA Healthcare System
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Behavioral Therapy Program | Experimental | Behavioral: Integrated Behavioral Therapy ProgramIntegrated 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 comparator | Behavioral: Health Education ProgramThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Behavioral Therapy ProgramIntegrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia | Behavioural | Integrated Behavioral Therapy Program |
| Health Education ProgramHealth 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. | Behavioural | Health Education Program |
Primary outcome
Mean Nocturia Frequency
Time frame: 4 months
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.
2 secondary outcomes
Self-Reported Insomnia Severity Index
Time frame: 4 months
Nocturia-Quality of Life
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 41692807Fung CH, Bolstad CJ, Huang A, Markland A, Cheng J, Alessi C, M Johnson T 2nd, Bliwise DL, Martin JL, Burgio KL, Schembri M, Der-McLeod E, Sergent T, Vaughan CP. An integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT): study protocol for a multi-site randomized clinical trial. Trials. 2026 Feb 16;27(1):226. doi: 10.1186/s13063-026-09464-2.
- Derived from this study: PubMed 41041560Fung 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E. Camille Vaughan, MD, MS principal investigator
Atlanta VAMC & Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behavioral Therapy Program and Health Education Program in people with Nocturia and Insomnia, run by Atlanta VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taressa Sergent ((404) 315-4100 ext. 373124, Taressa.Sergent@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Nocturia Frequency (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.