N/A
Completed N=30
Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Nocturia · Hypertension · Sleep Disturbances
Source: ClinicalTrials.gov NCT05419830 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention — -0.4; 7.3; 3.9 percentage of daytime mean SBP — p=0.65
Summary
In this study the investigators target three common and comorbid illnesses among older adults namely nocturia or waking at night to void, poor sleep and hypertension. The aim of this proposal is to test behavioral sleep intervention to improve sleep and nocturia vs switching the time of antihypertensive administration to improve nighttime and in turn daytime blood pressure control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention |
-0.4; 7.3; 3.9 | 0.65 |
| SECONDARY Change in Nocturia Frequency Pre- vs Post-intervention |
-0.3; -0.6; -0.3 | 0.66 |
| SECONDARY Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention |
0.5; -6.0; -0.9 | 0.14 |
| SECONDARY Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention |
0.5; -1.4; -1.2 | 0.2 |
| SECONDARY Change in Sleep Efficiency Pre- vs Post-intervention |
-7; 12; -3 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
The study shall include: ambulatory and functionally-independent community-dwelling men and women aged 65+ years, with
- nocturia ≥2/night, and
- history of high blood pressure and receives one or more non-diuretic, once daily antihypertensive- angiotensin converting enzyme inhibitor (ACE-I), angiotensin receptor blocker (ARB), calcium channel blocker (CCB), beta blocker
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
- Montreal cognitive assessment (MOCA) 14 alcohol drinks per week
- >3 caffeinated drinks (~300mg) per day
Data sourced from ClinicalTrials.gov (NCT05419830). 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. Informational only — not medical advice.