Obstructive Sleep Apnea
Conditions
Keywords
Children, Sleep, Obstructive Sleep Apnea
Brief summary
The investigators leading hypotheses are: * Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS. * A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.
Interventions
DRUGMontelukast
1 pill per day for 4 months
Sponsors
Merck Sharp & Dohme LLC
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for inclusion in the study will be symptomatic snoring children \>2 years of age and \< 10 years of age, who snore and have an apnea hypopnea index (AHI) \>2/hrTST (hour total sleep time), and in whom T&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. | 16 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Montelukast Montelukast: 1 pill per day for 16 weeks | 28 |
| Placebo Placebo: 1 pill per day for 16 weeks | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Montelukast | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 2.5 | 5.6 years STANDARD_DEVIATION 2.5 | 5.6 years STANDARD_DEVIATION 2.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 33 Participants | 17 Participants |
| Region of Enrollment United States | 28 participants | 57 participants | 29 participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 28 | 3 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.
Time frame: 16 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Montelukast | The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. | Reduction in AHI | 20 Participants |
| Montelukast | The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. | No reduction in AHI | 8 Participants |
| Placebo | The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. | Reduction in AHI | 2 Participants |
| Placebo | The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment. | No reduction in AHI | 27 Participants |
p-value: <0.001Fisher Exact