Table 2.
Outcome Measures Following Randomization for the INCS Arm Compared With the Placebo Group With Respect to Changes Between Baseline and Month 3 (Phase I of Study)
| Outcome | INCS |
Placebo |
Effect Size | P Value | ||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Month 3 | Change From Baseline to Month 3 | Baseline | Month 3 | Change From Baseline to Month 3 | |||
| Primary outcomea | ||||||||
| OAHI (N/h) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.0 | .77 |
| Median | 5.0 | 3.7 | –1.7 | 5.3 | 4.3 | –1.3 | ||
| IQR | 3.6 to 9.7 | 1.6 to 9.4 | –3.9 to 1.9 | 3.3 to 8.2 | 2.3 to 8.4 | –4.2 to 1.7 | ||
| Secondary outcomesb | ||||||||
| Participant-performed behavior and executive function testing | ||||||||
| Conners Kiddie Continuous Performance Test | ||||||||
| No. | 82 | 82 | 82 | 36 | 36 | 36 | 0.1 | |
| Median | 55.7 | 54.5 | 0.2 | 60.2 | 57.1 | –0.4 | ||
| IQR | 48.6 to 61.8 | 47.5 to 60.3 | –5.9 to 4.8 | 51.6 to 63.5 | 51.5 to 63.3 | –4.8 to 4.0 | ||
| Purdue Pegboard dominant hand | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.1 | |
| Median | –1.1 | –1.1 | 0.2 | –1.2 | –1.1 | 0.0 | ||
| IQR | –1.8 to –0.5 | –1.8 to –0.3 | –0.6 to 0.8 | –2.1 to –0.4 | –2.1 to –0.2 | –0.2 to 0.9 | ||
| Purdue Pegboard nondominant hand | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.4 | |
| Median | –1.2 | –1.1 | 0.0 | –1.2 | –0.8 | 0.2 | ||
| IQR | –1.9 to –0.5 | –1.8 to –0.3 | –0.6 to 0.9 | –2.3 to –0.5 | –1.9 to –0.2 | –0.2 to 1.4 | ||
| Purdue Pegboard both hands | ||||||||
| No. | 85 | 85 | 85 | 36 | 36 | 36 | 0.2 | |
| Median | –1.1 | –1.1 | 0.0 | –1.5 | –1.2 | 0.0 | ||
| IQR | –2.2 to –0.2 | –1.7 to –0.2 | –0.6 to 0.9 | –2.0 to –0.9 | –1.9 to –0.5 | –0.2 to 0.9 | ||
| Caregiver-reported behavior and executive function | ||||||||
| CGI (caregiver) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.1 | |
| Median | 5.0 | 5.5 | 0.0 | 4.5 | 3.0 | –0.5 | ||
| IQR | 2.0 to 14.0 | 2.0 to 12.0 | –2.0 to 2.0 | 1.0 to 10.5 | 0.0 to 8.0 | –2.0 to 1.0 | ||
| CBCL internalizing | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.1 | |
| Median | 52.0 | 52.0 | 0.0 | 51.0 | 48.0 | 0.0 | ||
| IQR | 45.0 to 59.0 | 45.0 to 59.0 | –6.0 to 4.0 | 41.0 to 58.0 | 34.0 to 58.0 | –6.0 to 3.0 | ||
| CBCL externalizing (caregiver) | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.0 | |
| Median | 53.0 | 50.0 | 0.0 | 44.0 | 44.0 | 0.0 | ||
| IQR | 46.0 to 59.0 | 46.0 to 59.0 | –6.0 to 4.0 | 34.0 to 56.0 | 35.0 to 54.0 | –4.0 to 3.0 | ||
| CBCL total problem (caregiver) | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.1 | |
| Median | 52.0 | 51.0 | 0.0 | 49.0 | 48.0 | 0.0 | ||
| IQR | 45.0 to 62.0 | 45.0 to 60.0 | –7.0 to 3.0 | 39.0 to 56.0 | 38.0 to 55.0 | –4.0 to 1.0 | ||
| CBCL attention subscale (caregiver) | ||||||||
| No. | 85 | 85 | 85 | 35 | 35 | 35 | 0.1 | |
| Median | 55.0 | 53.0 | 0.0 | 52.0 | 51.0 | 0.0 | ||
| IQR | 51.0 to 62.0 | 52.0 to 59.0 | –2.0 to 2.0 | 50.0 to 57.0 | 50.0 to 59.0 | –1.0 to 0.0 | ||
| BRIEF GEC (caregiver) | ||||||||
| Mean | ||||||||
| No. | 85 | 85 | 85 | 36 | 36 | 36 | 0.1 | |
| Median | 48.0 | 47.0 | 0.0 | 45.5 | 41.5 | –1.0 | ||
| IQR | 40.0 to 59.0 | 41.0 to 58.0 | –3.0 to 3.0 | 35.0 to 52.0 | 36.0 to 53.5 | –4.0 to 2.0 | ||
| Symptoms and health-related quality of life | ||||||||
| Modified Epworth Sleepiness Scale | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.1 | |
| Median | 9.0 | 7.0 | 0.0 | 6.0 | 5.5 | 0.0 | ||
| IQR | 5.0 to 12.0 | 4.0 to 13.0 | –4.0 to 2.0 | 3.5 to 11 | 2.0 to 11.5 | –2.5 to 2.0 | ||
| PSQ-SRBD scale | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.0 | |
| Median | 0.5 | 0.4 | 0.0 | 0.4 | 0.4 | 0.0 | ||
| IQR | 0.3 to 0.6 | 0.3 to 0.6 | –0.1 to 0.1 | 0.3 to 0.6 | 0.2 to 0.6 | –0.1 to 0.1 | ||
| PedsQL (total score) | ||||||||
| No. | 85 | 85 | 85 | 36 | 36 | 36 | 0.1 | |
| Median | 75.0 | 77.2 | 0.4 | 78.4 | 79.6 | 1.2 | ||
| IQR | 58.7 to 91.3 | 58.7 to 91.3 | –9.8 to 12.0 | 68.5 to 94.0 | 66.3 to 97.8 | –6.5 to 7.1 | ||
| OSA-18 (total score) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.2 | |
| Median | 50.0 | 40.5 | –6.0 | 43.0 | 36.0 | –5.5 | ||
| IQR | 37.0 to 60.0 | 30.0 to 56.0 | –18.0 to 4.0 | 31.0 to 54.5 | 25.0 to 53.5 | –12.0 to 4.0 | ||
| Nasal symptoms | ||||||||
| NOSE scale (total score) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.4 | |
| Median | 5.0 | 3.0 | 0.0 | 3.5 | 3.0 | 0.0 | ||
| IQR | 2.0 to 8.0 | 1.0 to 7.0 | –3.0 to 1.0 | 1.0 to 7.0 | 1.0 to 7.5 | –2.0 to 2.0 | ||
| Polysomnography | ||||||||
| % TST end-tidal CO2 > 50 mm Hg | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.2 | |
| Median | 0.2 | 0.3 | 0.0 | 0.1 | 0.1 | 0.0 | ||
| IQR | 0.0 to 2.4 | 0.0 to 1.3 | –0.8 to 0.6 | 0.0 to 1.5 | 0.0 to 0.80 | –0.7 to 0.3 | ||
| Arousal index (N/h) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.1 | |
| Median | 11.3 | 10.3 | –1.4 | 10.8 | 10.7 | –1.2 | ||
| IQR | 8.4 to 14.1 | 7.8 to 14.5 | –3.8 to 2.7 | 8.9 to 13.9 | 7.9 to 16.1 | –2.8 to 2.6 | ||
| % TST stage 1 | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.0 | |
| Median | 3.3 | 2.0 | –0.4 | 3.1 | 3.1 | 0.3 | ||
| IQR | 1.3 to 4.6 | 0.9 to 4.6 | –2.8 to 2.1 | 1.7 to 6.2 | 1.7 to 5.5 | –2.8 to 2.8 | ||
| % TST stage 2 | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.2 | |
| Median | 41.1 | 41.5 | 0.5 | 41.3 | 42.2 | 2.2 | ||
| IQR | 36.0 to 45.8 | 36.4 to 45.7 | –5.6 to 6.1 | 34.9 to 44.8 | 38.6 to 45.2 | –4.4 to 7.3 | ||
| % TST stage N3 | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.1 | |
| Mean | 34.8 | 33.5 | –1.3 | 34.8 | 34.3 | –0.5 | ||
| 95% CI | 33.3 to 36.3 | 31.9 to 35.1 | –3.1 to 0.4 | 32.4 to 37.1 | 31.9 to 36.5 | –3.7 to 2.7 | ||
| Time in stage REM (% TST) | ||||||||
| No. | 86 | 86 | 86 | 36 | 36 | 36 | 0.4 | |
| Mean | 20.6 | 22.0 | 1.4 | 20.6 | 19.6 | –1.0 | ||
| 95% CI | 19.5 to 21.7 | 20.9 to 23.1 | 0.1 to 2.7 | 18.9 to 22.3 | 17.7 to 21.5 | –3.3 to 1.2 | ||
Data are presented as mean ±SD or as medians with IQRs for nonnormally distributed data. The P value is provided for the primary outcome only and is adjusted for the stratification factors of atopy/asthma, current use of inhaled corticosteroids for asthma (yes/no, obesity status, and seasonality (spring/summer vs autumn/winter). Effect sizes were calculated with the use of Cohen’s d, the ratio of the absolute difference in means and the SD, and may be interpreted as: small, > 0.20 to 0.49; medium, 0.50 to 0.79; and large, ≥ 0.80. Note that the changes from 3 months to baseline are reported as median. Hence, displayed values do not necessarily match the 3-month and baseline cells, respectively. BRIEF GEC = Behavior Rating Inventory of 0Executive Function Global Executive Composite; CBCL = Child Behavior Checklist; CGI = Conners Global Index; INCS = intranasal corticosteroids; IQR = interquartile range; NOSE = Nasal Obstruction Symptom Evaluation; OAHI = obstructive apnea hypopnea index; OSA-18 = 18-item Obstructive Sleep Apnea assessment tool; PedsQL = Pediatric Quality of Life Inventory; PSQ-SRBD = Pediatric Sleep Questionnaire sleep-related breathing disorder scale; REM = rapid eye movement; TST = total sleep time.
Scores on the OAHI scale ranged from 0.3 to 61.9, with higher scores indicating greater severity.
Scores on the Conners Kiddie Continuous Performance Test scale ranged from 28 to 72.4, with higher scores indicating greater severity. Scores on the Purdue Pegboard dominant hand scale ranged from –4.7 to 5, with higher scores indicating greater severity. Scores on the Purdue Pegboard nondominant hand scale ranged from –5 to 6.9, with higher scores indicating greater severity. Scores on the Purdue Pegboard both hands scale ranged from –4.4 to 2.4, with higher scores indicating greater severity. Scores on the CGI ranged from 0 to 30, with higher scores indicating greater severity. Scores on the CBCL internalizing scale ranged from 29 to 81, with higher scores indicating greater severity. Scores on the CBCL externalizing scale ranged from 28 to 82, with higher scores indicating greater severity. Scores on the CBCL total problem scale ranged from 24 to 83, with higher scores indicating greater severity. Scores on the CBCL attention subscale ranged from 50 to 93, with higher scores indicating greater severity. Scores on the BRIEF GEC (caregiver-rated) scale ranged from 30 to 90, with higher scores indicating greater severity. Scores on the Modified Epworth Sleepiness Scale ranged from 0 to 24, with higher scores indicating greater severity. Scores on the PSQ-SRBD Scale ranged from 0 to .9, with higher scores indicating greater severity. Scores on the PedsQL scale ranged from 35.9 to 100, with higher scores indicating greater severity. Scores on the OSA-18 (total score) scale ranged from 18 to 112, with higher scores indicating greater severity. Scores on the NOSE scale ranged from 0 to 20, with higher scores indicating greater severity. Scores on the time with end-tidal CO2 > 50 mm Hg (% TST) scale ranged from 0 to 87.9, with higher scores indicating greater severity. Scores on the Arousal index scale ranged from 2 to 48.2, with higher scores indicating greater severity. Scores on the Time in stage 1 (% TST) scale ranged from 0 to 17.7. Scores on the Time in stage 2 (% TST) scale ranged from 18.9 to 71. Scores on the Time in stage 3 (% TST) scale ranged from 13 to 58.7. Scores on the Time in REM (% TST) scale ranged from 9.20 to 34.9.