Clinical Trial Search

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

Primary: 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

Primary: Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 — -2.01 Number of nocturnal voids

Primary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night

Primary: The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI)…

Primary: Change in Nocturia Episodes — 3.6; 3.3; 3.9; 3.6 average nightly voids — p=0.0017

Primary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night

Primary: Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment — -1.06; -0.99; -0.89; -0.80 nocturnal voids

Primary: Change in Nocturia Episodes — -1.2; -1.0 episodes

Primary: Change in # of Mean Nocturic Episodes Per Night — -1.4; -1.4; -1.6; -1.2 nocturic episodes per night

Primary: Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment — -1.4; -1.5; -1.2 nocturic episodes per night

Primary: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period — -1; -1.21; -1.25; -1.47 nocturnal voids — p=0.0280

Primary: Change From Baseline in Epworth Sleepiness Scale [ESS] — 9.03; 9.73 units on a scale

Primary: Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 — -0.86; -0.83; -1.00; -1.18 nocturnal voids — p=0.9303

Primary: Change From Baseline to Week 4 in sTST — 56.6; 35.7 minutes — p=0.002

Primary: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours — 2.93; 2.91 episodes per 24 hours

Primary: Change in Mean Number of Nocturnal Voids From Baseline — -1.63; -1.29 Voids — p=0.112

Primary: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period — -1.06; -0.973; -0.591; -1.4 nocturnal voids — p=<0.0001

Primary: Mean Serum Sodium — -0.0; -0.4; -0.4; -0.3 mmol/L

Primary: Serum Sodium Levels at Baseline and During Treatment — 141.0; 140.0; 139.2; 140.3 mmol/L

Primary: Change From Baseline in Mean Number of Nocturnal Voids — -1.12; -1.30; -1.42; -1.47 nocturnal voids

Primary: Number, Frequency and Severity of Product Related Adverse Events — 47; 63; 110; 5 Number of product related Adverse Events

Primary: Change in Balance — 6.66; 5.34; 5.62; 5.78 %CV

Primary: Change in the Number of Wet Nights Between Baseline and Treatment Period II — 3.264; 1.451 wet nights — p=0.009

Primary: Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian — -0.67 difference in number of dry nights

Primary: Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory) — 20; 20; 16 Participants

Primary: Impairment of Insulin Sensitivity — -0.80; 0.55 (mU/L)^-1 min^-1

Primary: Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1 — 0.00; 0.09; 2.00; 3.45 hours — p=0.211

Primary: Wet Nights — 2.4; 4.6 wet nights per week

Primary: Decrease in Nocturnal Enuresis — 16 Participants