Scheduled Awakenings for the Treatment of Nocturnal Enuresis

October 26, 2020 updated by: Benjamin Whittam, Indiana University
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hopspital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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: < 5 years of 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: One: Study Phases (S1 and S2)
The therapeutic phase of this study for the participant in Arm One will be: 6 weeks of behavioral modifications plus the Lully device (S1), followed by 6 weeks of behavioral modifications only without the device (S2)
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.
Other: Two: Study Phases (S2 and S1)
The therapeutic phase of this study for the participant in Arm Two will be: 6 weeks of behavioral modifications only without the device (S2), followed by 6 weeks of behavioral modifications plus use of the Lully device(S1)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian
Time Frame: baseline and 6 weeks (end of S1)
Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? Answered by yes or no.
baseline and 6 weeks (end of S1)
Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian
Time Frame: Not measured.
Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? (Answered by yes or no) What time?
Not measured.
Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully
Time Frame: Not measured.
Participants were asked to enter responses daily into a Lully Study app. In a free text box the family was asked to add additional information to describe how wet the child was using the following 1-5 scale: 1- wet underwear; 2-wet underwear and damp pajamas; 3- soaked underwear, pajamas; 4-soaked pajamas, damp mattress; 5- soaked mattress.
Not measured.
QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks
Time Frame: 10 weeks
Participants were asked to complete QOL survey (KIDSCREEN 27) at baseline, before starting therapeutic phase, and after completing therapeutic phase. KIDSCREEN is a standardized questionnaire for children and adolescents to assess their health related quality of life (HRQoL). Each items scored on a 5-point scale. There is the KIDSCREEN 54 (long version) KIDSCREEN 27 (short version) KIDSCREEN 10 Index. For analysis, decision made to analyze questions in the KIDSCREEN 10 Index questions only. For KIDSCREEN 10, it is a 5 point Likert Scale with a score range of 10 to 50 with higher scores indicating better quality of life.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Benjamin M Whittam, MD, Pediatric Urology, Riley Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2016

Primary Completion (Actual)

August 7, 2018

Study Completion (Actual)

August 7, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1601620278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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