At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of benign nocturnal enuresis
- ✓Age 5-17 years
- ✓Must have or have access to an Apple iPhone, iPad, or iPod Touch
- ✕Diurnal enuresis (daytime wetting)
- ✕Neurogenic bladder
- ✕Cerebral palsy
- ✕Epilepsy or seizure history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Scheduled Awakenings for the Treatment of Nocturnal Enuresis
In Brief
A clinical study evaluating Lully Sleep Guardian for Nocturnal Enuresis. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
Study Details
Timeline
Interventions
In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod. During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness. In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.
In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod. During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness. In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.