Clinical Trial: Scheduled Awakenings for the Treatment of Nocturnal Enuresis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Scheduled Awakenings for the Treatment of Nocturnal Enuresis

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

Detailed Summary:

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 G
Sponsor: Indiana University

Current Primary Outcome:

  • Change in number of dry nights when using the scheduled awakening protocol with the Lully Sleep Guardian [ Time Frame: Daily reporting during the 6 week Therapeutic Phase ]

    Family will be texted daily for this 6 weeks to document frequency of bed-wetting and severity while on therapeutic phase:

    1. "Did you use the Lully last night?"
    2. "Did your child wet the bed last night?"
  • Change in number of voids per night when using the scheduled awakening protocol with the Lully Sleep Guardian [ Time Frame: Daily reporting during the 6 week Therapeutic Phase ]

    Family will be texted daily for this 6 weeks to document frequency of bed-wetting and severity while on therapeutic phase:

    1. "Did you use the Lully last night?"
    2. "Did your child wet the bed last night?"
    3. "If yes, how wet was your child on scale of 1 - 5?" (1: wet underwear; 2: wet underwear and damp pajamas; 3: soaked underwear, pajamas; 4: soaked pajamas, damp mattress - 5: soaked mattress)
    4. "Did your child wake up to go to the bathroom last night?"
  • Change in quantity of wetness when bedwetting occurred while using the scheduled awakening protocol with the Lully [ Time Frame: Daily reporting during the 6 week Therapeutic Phase ]
    Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Indiana University

    Dates:
    Date Received: December 28, 2016
    Date Started: November 2016
    Date Completion: December 2017
    Last Updated: February 6, 2017
    Last Verified: February 2017