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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Peter Metcalfe, University of Alberta
ClinicalTrials.gov Identifier:
NCT01861145
First received: May 21, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Enuresis
Obstructive Sleep Apnea
Sleep Disordered Breathing
Device: Bed Alarm
Drug: Nasonex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Degree of improvement in enuresis after a 3 month trial of INS + bed alarm, compared to the bed alarm alone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in OSA-18 and PSQ-22 scores after 3 month trial of INS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse effects related to treatments [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Patient related differences ie obesity, age, sex, and the effect on continence/treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bed Alarm
Patients in the control arm will use only the bed alarm for treatment of their enuresis
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.
Other Name: Enuresis Alarm
Experimental: Bed alarm + intranasal steroids

Intervention: Nasonex (Mometasone furoate aqueous nasal spray) Children 5-11: 50 mcg/metered spray, 1 sprays in each nostril daily for 3 months in conjunction with nightly use of the bed alarm.

Children ≥ 12: 50 mcg/metered spray, 2 sprays in each nostril daily for 3 months in conjunction with nightly use of the bed alarm.

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.
Other Name: Enuresis Alarm
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.
Other Name: Mometasone Furoate Aqueous Nasal Spray

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages between 5-17
  • endorse 5/6 questions on the PSQ-22. These questions include: While sleeping, does your child: Ever snore? Snore more than half the time? Always snore? Snore loudly? Have "heavy" or loud breathing? Have trouble breathing, or struggle to breath?
  • desire to use the bed alarm

Exclusion Criteria:

  • Children <5
  • known neurological disorders resulting in neuropathic bowel or bladder disorder including, but not limited to spinal dysraphisms and spinal cord injuries.
  • significant congenital bladder anomalies, such as bladder exstrophy or posterior urethral valves
  • patients with craniofacial anomalies or syndromes known to be associated with obstructive sleep apnea (i.e. Trisomy 21, muccopolysaccardiosis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861145

Contacts
Contact: Peter D Metcalfe, MD (780) 407-3867

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Peter D Metcalfe, MD    (780)407-3867      
Principal Investigator: Peter D Metcalfe, MD         
Sub-Investigator: Trina Uwiera, MD         
Sub-Investigator: Alexandra Bascom, MD         
Synergy Respiratory Care Centre Recruiting
Sherwood Park, Alberta, Canada, T8H 0N2
Contact: Manisha Witmans, MD    (780) 800-6906      
Principal Investigator: Manisha Witmans, MD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Peter Metcalfe, MD Stollery Children's Hospital and the University of Alberta
  More Information

No publications provided

Responsible Party: Peter Metcalfe, Urologist, University of Alberta
ClinicalTrials.gov Identifier: NCT01861145     History of Changes
Other Study ID Numbers: Pro00032936
Study First Received: May 21, 2013
Last Updated: May 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Intranasal steroids

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Behavioral Symptoms
Dyssomnias
Elimination Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Urination Disorders
Urologic Diseases
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014