RECRUITING

Multi-center Trial to Improve Nocturia and Sleep in Older Adults

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)

Quick Facts

Study Start:2023-12-05

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06110091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Courtney E Hoge, MSPH

CONTACT

(404) 315-4100

Courtney.Hoge@va.gov

Taressa Sergent

CONTACT

(404) 315-4100

Taressa.Sergent@va.gov

Principal Investigator

E. Camille Vaughan, MD, MS

PRINCIPAL_INVESTIGATOR

Atlanta VAMC & Emory University

Study Locations (Sites)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 91343

United States

Atlanta VAHCS

Atlanta, Georgia, 30033

United States

Collaborators and Investigators

Sponsor: Atlanta VA Medical Center

E. Camille Vaughan, MD, MS, PRINCIPAL_INVESTIGATOR, Atlanta VAMC & Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05

Study Completion Date2028-08

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

Nocturia
Insomnia