Obstructive Sleep Apnea Clinical Trial
Official title:
Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea
Verified date | December 2015 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 17 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | Synergy Respiratory Care Centre | Sherwood Park | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of improvement in enuresis after a 3 month trial of INS + bed alarm, compared to the bed alarm alone. | 3 months | No | |
Secondary | Changes in OSA-18 and PSQ-22 scores after 3 month trial of INS | 3 months | No | |
Secondary | Adverse effects related to treatments | 3 months | Yes | |
Secondary | Patient related differences ie obesity, age, sex, and the effect on continence/treatment | 3 months | No |
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