Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

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.
    

Intervention name(s): Lully Sleep Guardian; Lully Sleep Guardian
Intervention type(s): Device; Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bedwetting