New study aims to help seniors sleep through the night
NCT ID NCT06110091
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests a combined treatment for older adults who wake up often to urinate and have trouble sleeping. The goal is to see if treating both problems together can reduce bathroom trips and improve sleep quality. Researchers will track changes over 4 months in 192 participants aged 60 and older.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2023
- Expected to finish
-
Aug 2028
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Insomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Atlanta VAHCS
RECRUITINGAtlanta, Georgia, 30033, United States
-
VA Greater Los Angeles Healthcare System
RECRUITINGLos Angeles, California, 91343, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Two bladder drugs face off over nighttime bathroom trips
- Does soreness after exercise disrupt sleep more for people with insomnia?
- Can fixing insomnia help heavy drinkers cut back?
- Can a sleep therapy program help control blood sugar in older diabetes patients?