NCT03047720

Scheduled Awakenings for the Treatment of Nocturnal Enuresis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.

Detailed description

Primary monosymptomatic nocturnal enuresis (PMNE) is defined by the Diagnostic \& Statistical Manual of Mental Disorders (DSM- IV) as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged \>5 years in the absence of congenital or acquired defects of the central nervous system(1-3). PMNE affects 10-20% kids at 5 years old (1, 4, 5). It does resolve spontaneously so that 5% of 10 year olds and 1% of 15 year olds are still affected (2-4). Is more common in boys. While the disease its self is benign, and improves without intervention, it does pose a significant social and emotional burden on the child and their family. These include parental disapproval, sibling teasing, and inability to attend sleep overs with peers, all of which lead to families seeking treatment options (3, 4). Current treatments start with conservative management. This includes appropriate fluid intake, scheduled toileting during the day, avoidance of bladder irritants and constipation (4, 5). If these fail to improve symptoms or families are looking for a more active form of treatment, first line therapy is either a bed wetting alarms or desmopressin (1, 4, 5). The Lully Sleep Guardian was initially developed for use in night terrors. The device works by programing a vibrating disk that is placed under the child's bed to alter sleep patterns and prevent the onset of sleep terrors. The child is not woken up for the treatment of sleep terrors. The device has also been shown to anecdotally improve users' nocturnal enuresis. There have been no reports of safety concerns or hazards with the device (7, 8). The aim of this study is to determine the effectiveness of scheduled awakenings, with the Lully Sleep Guardian, in patients with PMNE, at reducing the frequency of bed-wetting.

Conditions

• Nocturnal Enuresis

Interventions

Type	Name	Description
DEVICE	Lully Sleep Guardian	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.
DEVICE	Lully Sleep Guardian	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.

Timeline

• Start date: 2016-11-04
• Primary completion: 2018-08-07
• Completion: 2018-08-07
• First posted: 2017-02-09
• Last updated: 2020-11-17
• Results posted: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study