Trial Outcomes & Findings for Scheduled Awakenings for the Treatment of Nocturnal Enuresis (NCT NCT03047720)

Last Updated: 2020-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline and 6 weeks (end of S1)

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Lully Device First, Then No Device Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2) No washout period between S1 and S2 because there was no carryover effect from either intervention	No Device First, Then Lully Device Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1) No washout period between S2 and S1 because there was no carryover effect from either intervention
First Intervention (6weeks) STARTED	12	0
First Intervention (6weeks) COMPLETED	5	0
First Intervention (6weeks) NOT COMPLETED	7	0
Second Intervention (6weeks) STARTED	0	0
Second Intervention (6weeks) COMPLETED	0	0
Second Intervention (6weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lully Device First, Then No Device Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2) No washout period between S1 and S2 because there was no carryover effect from either intervention	No Device First, Then Lully Device Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1) No washout period between S2 and S1 because there was no carryover effect from either intervention
First Intervention (6weeks) Participant data entry insufficient	7	0

Baseline Characteristics

Scheduled Awakenings for the Treatment of Nocturnal Enuresis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lully Device First, Then No Device n=12 Participants Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2) No washout period between S1 and S2 because there was no carryover effect from either intervention	No Device First, Then Lully Device Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1) No washout period between S2 and S1 because there was no carryover effect from either intervention	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	—	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Vancouver Questionnaire Score	9.28 units on a scale STANDARD_DEVIATION 3.10 • n=5 Participants	—	9.28 units on a scale STANDARD_DEVIATION 3.10 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks (end of S1)

Population: Participants who completed at least 37 nights of data entry using the scheduled awakening protocol with the Lully Sleep Guardian

Outcome measures

Outcome measures
Measure	Lully Device n=5 Participants Participants who completed 6 weeks of behavioral modifications plus the Lully device	No Device Participants who completed 6 weeks of behavioral modifications only without the device
Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian	-0.67 difference in number of dry nights Interval -3.0 to 2.0	—

PRIMARY outcome

Timeframe: Not measured.

Population: Unable to measure because data was not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Not measured.

Population: No participant were analyzed. Data was not available. Contributors: data not entered by participants and app glitches could have lead to lost data if entered

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 10 weeks

Population: Patients analyzed completed the KIDSCREEN after completing the 6 weeks use of the Lully device. 4 of 5 who completed the 6 weeks use the Lully device completed the KIDSCREEN. Data was not collected for Baseline and 4 wk scores.

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.

Outcome measures

Outcome measures
Measure	Lully Device n=4 Participants Participants who completed 6 weeks of behavioral modifications plus the Lully device	No Device Participants who completed 6 weeks of behavioral modifications only without the device
QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks	42.75 score on a scale Standard Deviation 5.97	—

Adverse Events

S1: Lully Device Plus Behavioral Modifications

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

S2: Behavioral Modifications Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Benjamin Whittam

Indiana University

Phone: 317.944.8896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place