Nocturnal EnuresisNCT03047720
Scheduled Awakenings for the Treatment of Nocturnal Enuresis
A study testing Lully Sleep Guardian in people with Nocturnal Enuresis, run by Indiana University at 1 site in United States.
Trial summary
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Lully Sleep Guardian
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2016to 7 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Benign nocturnal enuresis
- Age: 5 - 17
- Must have or have access to an Apple iPhone, iPad, or iPod Touch
Who cannot join
- 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
Show all 11Show fewer
- Cerebral Palsy
- Mental disorders, mood disorders, or autism-spectrum disorder
- Epilepsy or seizure history
- Restless leg syndrome
- Use of benzodiazepine/clonidine
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hopspital for Children
Indianapolis, Indiana, 46202
About this study
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
Read the 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.
- Conditions
- Nocturnal Enuresis
- Being tested
- Lully Sleep Guardian
- Keywords
- bedwetting
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lully Sleep GuardianDevice
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.
Lully Sleep GuardianDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| One: Study Phases (S1 and S2) | Other | 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) Receives: Device: Lully Sleep Guardian |
| Two: Study Phases (S2 and S1) | Other | 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) Receives: Device: Lully Sleep Guardian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian
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.
Measured: 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
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?
Measured: Not measured.
Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully
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.
Measured: Not measured.
QOL Measures Using the KIDS Screen Questionnaire at 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start4 Nov 2016
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Whittam, Indiana University
- Investigators
- Benjamin M Whittam, MD, Principal investigator, Pediatric Urology, Riley Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047720
- Sponsor's protocol ID
- 1601620278
- Status last verified
- Oct 2020
- First submitted
- 28 Dec 2016
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
National Clinical Guideline Centre (UK). Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK62712/
PubMed 22031959Ahmed AF, Amin MM, Ali MM, Shalaby EA. Efficacy of an enuresis alarm, desmopressin, and combination therapy in the treatment of saudi children with primary monosymptomatic nocturnal enuresis. Korean J Urol. 2013 Nov;54(11):783-90. doi: 10.4111/kju.2013.54.11.783. Epub 2013 Nov 6.
PubMed 24255762Glazener CM, Evans JH, Peto RE. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2003;(2):CD002911. doi: 10.1002/14651858.CD002911.
PubMed 12804443Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.
PubMed 25086164Monda JM, Husmann DA. Primary nocturnal enuresis: a comparison among observation, imipramine, desmopressin acetate and bed-wetting alarm systems. J Urol. 1995 Aug;154(2 Pt 2):745-8.
PubMed 7609169Onol FF, Guzel R, Tahra A, Kaya C, Boylu U. Comparison of long-term efficacy of desmopressin lyophilisate and enuretic alarm for monosymptomatic enuresis and assessment of predictive factors for success: a randomized prospective trial. J Urol. 2015 Feb;193(2):655-61. doi: 10.1016/j.juro.2014.08.088. Epub 2014 Aug 23.
PubMed 251582737.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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheduled Awakenings for the Treatment of Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT03047720
- Acronym / sponsor ID
- 1601620278
- Conditions
- Nocturnal Enuresis
- Keywords
- bedwetting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One: Study Phases (S1 and S2) | Other | Device: Lully Sleep GuardianThe 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) |
| Two: Study Phases (S2 and S1) | Other | Device: Lully Sleep GuardianThe 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) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Benign nocturnal enuresis
- Age: 5 - 17
- Must have or have access to an Apple iPhone, iPad, or iPod Touch
Key exclusion criteria (11 listed)
- Diurnal Enuresis
- Constipation
- Neurogenic Bladder
- Any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage
- Any bladder active medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lully Sleep GuardianIn 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 | One: Study Phases (S1 and S2) |
| Lully Sleep GuardianIn 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 | Two: Study Phases (S2 and S1) |
Primary outcome
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.
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?
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22031959National Clinical Guideline Centre (UK). Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK62712/
- Background: PubMed 24255762Ahmed AF, Amin MM, Ali MM, Shalaby EA. Efficacy of an enuresis alarm, desmopressin, and combination therapy in the treatment of saudi children with primary monosymptomatic nocturnal enuresis. Korean J Urol. 2013 Nov;54(11):783-90. doi: 10.4111/kju.2013.54.11.783. Epub 2013 Nov 6.
- Background: PubMed 12804443Glazener CM, Evans JH, Peto RE. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2003;(2):CD002911. doi: 10.1002/14651858.CD002911.
- Background: PubMed 25086164Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.
- Background: PubMed 7609169Monda JM, Husmann DA. Primary nocturnal enuresis: a comparison among observation, imipramine, desmopressin acetate and bed-wetting alarm systems. J Urol. 1995 Aug;154(2 Pt 2):745-8.
- Background: PubMed 25158273Onol FF, Guzel R, Tahra A, Kaya C, Boylu U. Comparison of long-term efficacy of desmopressin lyophilisate and enuretic alarm for monosymptomatic enuresis and assessment of predictive factors for success: a randomized prospective trial. J Urol. 2015 Feb;193(2):655-61. doi: 10.1016/j.juro.2014.08.088. Epub 2014 Aug 23.
- Background7.Rink A. Lully Sleep Guardian. In: Heinsimer K, editor. IU Health2016.
- Background8. 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Whittam, MD principal investigator
Pediatric Urology, Riley Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lully Sleep Guardian in people with Nocturnal Enuresis, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047720, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.