Scheduled Awakenings for the Treatment of Nocturnal Enuresis

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 4, 2016

Primary Completion Date

August 7, 2018

Study Completion Date

August 7, 2018

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."

Trial Locations (1)

46202

Riley Hopspital for Children, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER

NCT03047720 - Scheduled Awakenings for the Treatment of Nocturnal Enuresis | Biotech Hunter | Biotech Hunter