N/A
N=12
Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Nocturnal Enuresis
Bottom Line
View on ClinicalTrials.gov: NCT03047720 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lully Sleep Guardian (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian |
-0.67 | — |
| PRIMARY Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian |
— | — |
| PRIMARY Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully |
— | — |
| PRIMARY QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks |
42.75 | — |
Summary
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
Eligibility Criteria
Inclusion Criteria
- Benign nocturnal enuresis
- Age: 5 - 17
- Must have or have access to an Apple iPhone, iPad, or iPod Touch
Exclusion Criteria
- Diurnal Enuresis
- Constipation
- Neurogenic Bladder
- Any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage
- Any bladder active medications
- Age: 17 years of age
- Cerebral Palsy
- Mental disorders, mood disorders, or autism-spectrum disorder
- Epilepsy or seizure history
- Restless leg syndrome
- Use of benzodiazepine/clonidine
Data sourced from ClinicalTrials.gov (NCT03047720). 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.