MedTrace Logo

Scheduled Awakenings for the Treatment of Nocturnal Enuresis

NCT03047720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-17

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Nocturnal Enuresis

Interventions

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.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Benjamin M Whittam, MD · Pediatric Urology, Riley Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-04
Primary Completion
2018-08-07
Completion
2018-08-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047720 on ClinicalTrials.gov