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

Insomnia Clinical Trial

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

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Insomnia
• Nocturia

• NCT number: NCT06110091
• Study type: Interventional
• Source: Atlanta VA Medical Center
• Contact: Courtney E Hoge, MSPH
• Phone: (404) 315-4100
• Email: Courtney.Hoge@va.gov
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Completion date: August 2028