Scheduled Awakenings for the Treatment of Nocturnal Enuresis

Indiana University

Status: Completed

Conditions: Nocturnal Enuresis

Treatments: Device: Lully Sleep Guardian

Study type: Interventional

Funder types: Other

Identifiers

NCT03047720

1601620278

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

One: Study Phases (S1 and S2)

Other group

Description:

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)

Treatment:

Device: Lully Sleep Guardian

Two: Study Phases (S2 and S1)

Other group

Description:

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)

Treatment:

Device: Lully Sleep Guardian