CompletedNot Applicable

Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

United States56 participantsStarted 2019-02-01

Plain-language summary

Nocturia is prevalent in older adults and it vastly reduces quality of life. Yet its treatment remains inadequate because its causes are not well understood, especially nocturnal polyuria or increased urine production at night. This study, which builds on the investigators' ongoing research, would be the first of its kind to explore the role of sleep in nighttime urine production. The findings will contribute important knowledge to guide development of better targeted and more effective therapy for this prevalent and morbid condition.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ambulatory and functionally-independent community-dwelling men and women * aged 65 years, or more * with nocturia ≥2/night * poor sleep because of frequent awakenings Exclusion Criteria: * Unstable or acute medical or central nervous system conditions * Untreated, current, severe psychiatric condition * Untreated, current, severe overactive bladder syndrome * Post void residual \> 30ml * Sleep apnea with AHI≥15 * Currently diagnosed and/or treated Obstructive Sleep Apnea, Restless Legs Syndrome, parasomnia * Congestive heart failure, by exam or Beta natriuretic peptide (BNP)\> 30 pmol/L * Chronic kidney disease, stage III-V (eGFR\<50) * \>14 alcohol drinks per week

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Nocturnal Polyuria Index

Timeframe: change from baseline nocturnal polyuria index at 4 weeks

Trial details

NCT IDNCT03883724

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

Results submitted2022-11-25

View on ClinicalTrials.gov More Sleep Fragmentation trials