Obstructive Sleep Apnea Clinical Trial
Official title:
Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea
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.
Enuresis (E) is a common pediatric urological complaint. Up to 15% of 5-year old children
and 5% of 10-year old children are affected. Despite its prevalence, E is often
ineffectively managed. Current treatment modalities include behavior modification, alarm
therapy, and pharmacologic treatment. Recently, a significant amount of contemporary
research has focused on sleep-disordered breathing (SDB) and its relation to E. This term
encompasses a variety of disorders characterized by abnormalities of respiratory pattern or
the quantity of ventilation during sleep. Often symptoms of OSA in children may be insidious
in nature, and include behavioural problems, hyperactivity, poor school performance, failure
to thrive and enuresis.
The relationship between E and OSA has only recently been questioned. Cinar et al.
demonstrated 63% complete resolution and 4% partial resolution of E post surgical treatment
of upper airway obstruction. Basha et al. had a similar result, with 61.4% of patients
having total resolution of NE. The investigators have previously published results on the
incidence of SDB in the enuretic population. Using the OSA-18 and PSQ-22 as screening tools
for the symptoms of SDB, the investigators found that a significant proportion of patients
with enuresis have SDB and the risk is further magnified in patients with abnormal daytime
voiding.
The pathophysiology of this relationship is currently under review. With cystometrography,
Brooks et al. demonstrated an increase in bladder pressure from 5 to 60 cm H2O with
increasing respiratory efforts. Mahler et al. demonstrated that in healthy children exposed
to sleep deprivation, disruption in the circadian rhythm resulted in a 68% increase in urine
volume, a significant increase in sodium excretion, clearance, and fractional excretion.
Sleep deprivation also resulted in higher nighttime blood pressure, and heart rate, which
affected sodium regulating hormones, including the renin-angiotension-aldosterone system and
ANP. Apneic episodes result in similar fluctuations in sodium excretion, by causing an
increase in intrathoracic pressure, increased stretch of the cardiomyocytes, and excretion
of atrial and brain natriuretic peptides. Finally, the overall disruption in sleep due to
SDB may be the ultimate factor. Healthy children with sleep deprivation demonstrated
increased naturiesis, and Yeung et al. demonstration that children with E have abnormal
sleep EEG activity with impaired arousability, increased light non-REM sleep, frequent
cortical arousals, and impaired wakening.
Enuresis is difficult to treat, and conventional modalities rarely achieve success rates
greater than 65%. According to several systematic reviews, enuresis alarms have the highest
efficacy rate, and result in an increase in the number of dry nights per week by 4. In a
study by Monda et al., 66% of children using enuresis alarms achieved continence by 6
months. Alarms may also reduce treatment failure and relapse that is often associated with
the use of medications such as tricyclic antidepressants. Enuresis alarms use a moisture
sensor that activates as soon as the child begins to void.
In children, SDB is primarily caused by adenotonsillar hypertrophy, and treatment for OSA
begins with a three-month trial of intranasal steroids (INS). INS act by directly reducing
adenoidal size by lympholytic action, reducing inflammation, and decreasing the significance
of adenoids as a reservoir for infection. In a recent meta-analysis, INS were found to
reduce the symptoms of snoring, mouth breathing, and nasal speech by 45-50% when compared to
placebo. Similarly, Demirhan et al. showed a mean decrease of adenoid/choana ratio from
86.9% to 56.2% after 8 weeks of fluticasone. In a recent meta-analysis, Zhang et al. found
that 5/6 trials showed a significant improvement in nasal obstruction symptoms and reduction
in adenoid size with the use of INS.
The investigators' previous data has shown that children with symptoms of SDB and E do not
respond to conventional management of E. The investigators therefore propose to trial a
novel management approach, by treating the symptoms of SDB with intranasal steroids, in
hopes of improving patient's enuresis.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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