N/A N=56 Randomized Other

Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production

Sleep Fragmentation · Poor Quality Sleep · Nocturia · Nocturnal Enuresis

Bottom Line

View on ClinicalTrials.gov: NCT03883724 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Change in Nocturnal Polyuria Index — 41.7; 41.7; 34.5; 37.8 percentage of urine volume — p=0.3

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brief behavioral treatment of insomnia (BBTI) (Behavioral); Information-only control (IC) (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Nocturnal Polyuria Index	41.7; 41.7; 34.5; 37.8	0.3
SECONDARY Change in Nocturia	2.3; 2.1; 1.3; 1.8	<.01 sig
SECONDARY Change in Duration of Uninterrupted Sleep	174; 188; 227; 210	0.3

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.

Eligibility Criteria

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 14 alcohol drinks per week

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03883724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.