Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Scheduled Awakenings for the Treatment of Nocturnal Enuresis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03047720
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Benjamin Whittam, Indiana University

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

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Device: Lully Sleep Guardian Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Actual Study Start Date : November 4, 2016
Actual Primary Completion Date : August 7, 2018
Actual Study Completion Date : August 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
One
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.


Two
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.





Primary Outcome Measures :
  1. Change in number of dry nights when using the scheduled awakening protocol with the Lully Sleep Guardian [ Time Frame: Participant data reported daily reported daily during the Initial and Therapeutic Phases ]
  2. Change in number of voids per night when using the scheduled awakening protocol with the Lully Sleep Guardian [ Time Frame: Participant data reported daily reported daily during the Initial and Therapeutic Phases ]
  3. Change in quantity of wetness when bedwetting occurred while using the scheduled awakening protocol with the Lully [ Time Frame: Participant data reported daily reported daily during the Initial and Therapeutic Phases ]
  4. Change in QOL measures using the KIDS Screen Questionnaire comparing baseline, therapeutic phase, and follow up [ Time Frame: Questionnaire completed before starting initial phase, before starting therapeutic phase, at the cross-over between the study phases ( S1 and S2), and at the completion of therapeutic phase ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047720


Locations
Layout table for location information
United States, Indiana
Riley Hopspital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Benjamin M Whittam, MD Pediatric Urology, Riley Children's Hospital
Publications:
1. National Clinical Guideline C. National Institute for Health and Clinical Excellence: Guidance. Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK) National Clinical Guideline Centre.; 2010.
7.Rink A. Lully Sleep Guardian. In: Heinsimer K, editor. IU Health2016.
8. Lully Sleep Guardian - Proven to Stop Night Terrors: Amazon; 2016 [cited 2015 2016]. Available from: http://www.amazon.com/Lully-Sleep-Guardian-Proven-Terrors/dp/B011LOUNCI/ref=sr_1_1?ie=UTF8&qid=1457660065&sr=8-1-spons&keywords=lully+sleep+guardian&psc=1#customerReviews.

Layout table for additonal information
Responsible Party: Benjamin Whittam, Assistant Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT03047720    
Other Study ID Numbers: 1601620278
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Benjamin Whittam, Indiana University:
bedwetting
Additional relevant MeSH terms:
Layout table for MeSH terms
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms