Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea

NCT01861145 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-12-18

No results posted yet for this study

Summary

Enuresis (E) or bedwetting is a common pediatric complaint, and recent research has discovered a link with obstructive sleep apnea (OSA). In children, OSA is often secondary to enlargement of their adenoids or tonsils, and is often successfully treated with a steroid solution given through the nose.

The relationship between SDB and E is incompletely understood. Airway obstruction affects the quality of sleep, as the child will wake as the oxygen levels drop. Abnormal sleep also can decrease the secretion of hormones that affects the kidney's ability to concentrate urine at night, which can result in too much urine in the bladder. Contemporary evidence also suggests that patients with enuresis have abnormal sleep phases, which may impair the communications and inhibition of the bladder.

In previous studies, the investigators have demonstrated that children with E have a high likelihood of having concomitant SDB. The investigators have also demonstrated that children with E and symptoms of SDB do not respond to typical management for bedwetting. Therefore, the investigators propose to treat patients presenting with E with our standard treatments for E (bed alarm) and first line therapy for SDB: Intranasal steroids. This medication helps to decrease the inflammation of the adenoids and tonsils, thereby reducing the airway obstruction. the investigators hypothesize that children with significant symptoms of SDB will improve with the addition of INS, and the investigators hope to see an improvement in their bedwetting, quality of life, and sleep quality as well.

To test this, patents with E will be recruited from the pediatric urology clinic. They will be offered the standard treatment for E, the bed alarm, and the treatment group will be given an intranasal steroid spray. The investigators will then reassess the patients 3 months after treatment, and compare the two groups.

Conditions

Interventions

DEVICE

Bed Alarm

The bed alarm is a device that is worn at night with a sensor in the child's underwear. The alarm will activate when the child urinates, helping the brain to link the sensation of a full bladder with wakening.

DRUG

Nasonex

Intranasal steroids are used by otolaryngologists as first line treatment for adenotonsillar hypertrophy in children with suspected sleep-disordered breathing and obstructive sleep apnea. The spray helps to shrink the size of the adenoids and tonsils, diminishing the amount of tissue obstructing the child's airway.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Peter Metcalfe, MD · Stollery Children's Hospital and the University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • Canada

Study Locations

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Entities

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 NCT01861145 on ClinicalTrials.gov