Table 3.
Outcome Measures for Patients Who Received Intranasal Corticosteroids at Baseline, 3 Months, and 12 Months
| Outcome | Baseline | Month 3 | Month 12 | Change From Baseline to Month 12 | Effect Size | P Value∗ From Paired t test |
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| OAHI (No./h) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.352 | .039 |
| Mean (95% CI) | 7.70 (5.82 to 9.57) | 5.63 (3.52 to 7.74) | 5.37 (3.51 to 7.23) | –2.33 (–4.54 to –.12) | ||
| Median (Q1 to Q3) | 7.20 (3.62 to 9.88) | 3.5 (1.55 to 7.10) | 3.70 (1.56 to 6.40) | –1.76 (–4.27 to 1.44) | ||
| Secondary outcomes | ||||||
| Participant-performed behavior and executive function testing | ||||||
| Conners Kiddie Continuous Performance Test | 36 | 36 | 36 | 36 | 0.219 | .204 |
| No. | ||||||
| Mean (95% CI) | 55.34 (52.17 to 58.51) | 53.95 (50.84 to 57.06) | 53.14 (49.39 to 56.89) | –2.2 (–5.65 to 1.25) | ||
| Median (Q1 to Q3) | 57.12 (48.57 to 62.65) | 53.88 (47.13 to 60.33) | 54.09 (43.72 to 64.13) | –1.64 (–5.07 to 3.96) | ||
| Purdue Pegboard dominant hand | ||||||
| No. | 38 | 38 | 38 | 38 | 0.049 | .769 |
| Mean (95% CI) | –1.03 (–1.36 to –0.70) | –1.07 (–1.5 to –0.65) | –1.12 (–1.71 to –0.52) | –0.09 (–0.71 to 0.53) | ||
| Median (Q1 to Q3) | –1 (–1.62 to –0.5) | –1.16 (–1.77 to –0.5) | –1.04 (–1.72 to 0.08) | –0.01 (–0.75 to 0.92) | ||
| Purdue Pegboard both hands | ||||||
| No. | 38 | 38 | 38 | 38 | 0.028 | .865 |
| Mean (95% CI) | 1.02 (–1.45 to –0.6) | –.950 (–1.34 to –0.57) | –.98 (–1.34 to –0.62 | 0.04 (–0.48 to 0.57) | ||
| Median (Q1 to Q3) | –1.05 (–1.96 to –0.29) | –.81 (–1.68 to –0.18) | –.88 (–1.5 to –0.29) | –0.15 (–0.91 to 0.83) | ||
| Purdue Pegboard nondominant hand | ||||||
| No. | 38 | 38 | 38 | 38 | 0.03 | .857 |
| Mean (95% CI) | –1.05 (–1.65 to –0.46) | –1.01 (–1.42 to –0.61) | –.99 (–1.36 to –0.62) | 0.06 (–0.59 to 0.70) | ||
| Median (Q1 to Q3) | –1.27 (–1.89 to –0.71) | –1.07 (–1.58 to –0.23) | –.86 (–1.45 to –0.31) | 0.43 (–0.56 to 1.09) | ||
| Caregiver-reported behavior and executive function | ||||||
| CGI | ||||||
| No. | 36 | 36 | 36 | 36 | 0.318 | .064 |
| Mean (95% CI) | 7.14 (4.55 to 9.73) | 7.47 (5.01 to 9.94) | 5.75 (3.82 to 7.68) | –1.39 (–2.87 to 0.09) | ||
| Median (Q1 to Q3) | 4 (1.5 to 11.5) | 5.5 (3 to 9.5) | 5 (1 to 8.5) | –1 (–5 to 1.5) | ||
| CBCL internalizing | ||||||
| No. | 38 | 38 | 38 | 38 | 0.233 | .164 |
| Mean (95% CI) | 51.76 (48.63 to 54.89) | 50.57 (47.83 to 53.31) | 49.7 (46.75 to 52.66) | –2.05 (–4.99 to 0.88) | ||
| Median (Q1 to Q3) | 52 (45 to 57) | 50 (46 to 58) | 50 (43 to 57) | –2 (–6 to 4) | ||
| CBCL externalizing | ||||||
| No. | 38 | 38 | 38 | 38 | 0.118 | .477 |
| Mean (95% CI) | 53.19 (49.4 to 56.97) | 54.08 (50.12 to 58.04) | 52.19 (48.7 to 55.67) | –1 (–3.82 to 1.82) | ||
| Median (Q1 to Q3) | 51 (46 to 59) | 50 (47 to 61) | 53 (44 to 58) | 0 (–7 to 5) | ||
| CBCL total problem | ||||||
| No. | 38 | 38 | 38 | 38 | 0.147 | .376 |
| Mean (95% CI) | 52.7 (49.27 to 56.14) | 52.51 (49.06 to 55.96) | 51.62 (48.58 to 54.67) | –1.08 (–3.53 to 1.38) | ||
| Median (Q1 to Q3) | 50 (45 to 57) | 51 (47 to 56) | 51 (45 to 58) | –1 (–5 to 4) | ||
| CBCL attention subscale | ||||||
| No. | 38 | 38 | 38 | 38 | 0.175 | . 295 |
| Mean (95% CI) | 56.32 (54.04 to 58.61) | 56.16 (54.28 to 58.05) | 55.27 (53.59 to 56.95) | –1.05 (–3.07 to 0.96) | ||
| Median (Q1 to Q3) | 53 (52 to 61) | 55 (52 to 57) | 53 (52 to 57) | 0 (–3 to 2) | ||
| BRIEF GEC | ||||||
| No. | 38 | 38 | 38 | 38 | 0.312 | . 066 |
| Mean (95% CI) | 50.03 (46.2 to 53.85) | 50.41 (46.03 to 54.78) | 47.7 (44.16 to 51.25) | –2.32 (–4.81 to 0.16) | ||
| Median (Q1 to Q3) | 46 (42 to 58) | 45 (42 to 58) | 42 (40 to 56) | –2 (–5 to 1) | ||
| Symptoms and health quality of life | ||||||
| Modified Epworth Sleepiness Scale | ||||||
| No. | 38 | 38 | 38 | 38 | 0.328 | .054 |
| Mean (95% CI) | 9.22 (7.64 to 10.79) | 8.38 (6.60 to 10.16) | 7.86 (6.43 to 9.30) | –1.35 (–2.73 to 0.02) | ||
| Median (Q1 to Q3) | 9 (6 to 12) | 9 (4 to 12) | 8 (4 to 11) | –2 (–3 to 2) | ||
| PSQ-SRBD scale | ||||||
| No. | 38 | 38 | 38 | 38 | 0.5 | .004 |
| Mean (95% CI) | 0.44 (0.39 to 0.49) | 0.38 (0.31 to 0.45) | 36 (0.3 to 0.42) | –0.08 (–0.14 to –0.03) | ||
| Median (Q1 to Q3) | 0.45 (0.32 to 0.570) | 0.36 (0.23 to 0.52) | 0.36 (0.23 to 0.5) | –0.05 (–0.21 to 0.03) | ||
| PedsQL | ||||||
| No. | 38 | 38 | 38 | 38 | 0.073 | .662 |
| Mean (95% CI) | 76.82 (71.36 to 82.29) | 75.85 (69.87 to 81.83) | 78.29 (72.43 to 84.15) | 1.47 (–5.29 to 8.22) | ||
| Median (Q1 to Q3) | 83.7 (63.04 to 92.39) | 81.52 (58.7 to 89.13) | 85.87 (66.3 to 92.39) | 0 (–6.52 to 8.70) | ||
| OSA-18 (total score) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.557 | .002 |
| Mean (95% CI) | 45.97 (41.27 to 50.67) | 40.95 (36.19 to 45.7) | 37.59 (33.07 to 42.12) | –8.38 (–13.4 to –3.36) | ||
| Median (Q1 to Q3) | 45 (36 to 55) | 40 (29 to 49) | 36 (29 to 47) | –8 (–15 to 3) | ||
| Nasal symptoms | ||||||
| NOSE scale | ||||||
| No. | 38 | 38 | 38 | 38 | ||
| Mean (95% CI) | 4.76 (3.61 to 5.9) | 4.03 (2.82 to 5.24) | 3.65 (2.5 to 4.79) | –1.11 (–2.2 to –0.01) | 0.338 | .047 |
| Median (Q1 to Q3) | 5 (2 to 6) | 2 (1 to 7) | 2 (1 to 6) | –1 (–3 to 1) | ||
| Polysomnography | ||||||
| % TST end-tidal CO2 > 50 mm Hg) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.326 | .055 |
| Mean (95% CI) | 6.2 (1.75 to 10.65) | 2.09 (–.37 to 4.55) | 1.92 (.47 to 3.37) | –4.28 (–8.66 to 0.09) | ||
| Median (Q1 to Q3) | 0.3 (0 to 4.4) | 0.2 (0 to 0.700) | 0.1 (0 to 1) | –0.1 (–3.5 to 0) | ||
| Arousal index (N/h) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.489 | .005 |
| Mean (95% CI) | 12.58 (11.2 to 13.96) | 11.69 (9.91 to 13.47) | 10.52 (8.93 to 12.1) | –2.06 (–3.46 to –0.66) | ||
| Median (Q1 to Q3) | 12.6 (9.78 to 15.51) | 10.54 (9.22 to 14.5) | 9.9 (7.07 to 13.6) | –2.66 (–4.66 to 1.1) | ||
| Time in stage 1 (% TST) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.031 | .85 |
| Mean (95% CI) | 4 (2.96 to 5.03) | 3.66 (2.49 to 4.83) | 3.86 (2.84 to 4.88) | –.13 (–1.53 to 1.26) | ||
| Median (Q1 to Q3) | 3.72 (1.27 to 5.08) | 2.3 (.9 to 6) | 3.38 (1.3 to 6) | –.560 (–3.35 to 2.07) | ||
| Time in stage 2 (% TST) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.156 | .348 |
| Mean (95% CI) | 40.86 (38.26 to 43.46) | 40.2 (37.21 to 43.19) | 42.45 (39.36 to 45.54) | 1.59 (–1.79 to 4.96) | ||
| Median (Q1 to Q3) | 41.1 (35.5 to 45.91) | 39.35 (36.41 to 46.8) | 41.79 (37.53 to 47.9 | 3.19 (–1.71 to 6.29) | ||
| Time in stage N3 (% TST) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.334 | .05 |
| Mean (95% CI) | 35.45 (33.05 to 37.84) | 34.16 (31.58 to 36.73) | 32.45 (29.54 to 35.36) | –3 (–5.99 to –0.01) | ||
| Median (Q1 to Q3) | 34.58 (30.12 to 39.77) | 34.1 (28.8 to 37.3) | 30.83 (28.01 to 38.6) | –4.7 (–8.80 to 0.59) | ||
| Time in stage REM (% TST) | ||||||
| No. | 38 | 38 | 38 | 38 | 0.216 | .197 |
| Mean (95% CI) | 19.69 (18.06 to 21.33) | 21.98 (20.21 to 23.76) | 21.24 (19.07 to 23.41) | 1.55 (–0.84 to 3.94) | ||
| Median (Q1 to Q3) | 19.53 (16.8 to 22.33) | 21.66 (18.68 to 26.19) | 21.6 (18.1 to 25.1) | 1.42 (–2.5 to 5.83) |
BRIEF GEC = Behavior Rating Inventory of Executive Function Global Executive Composite; CBCL = Child Behavior Checklist; CGI = Conners Global Index; NOSE = Nasal Obstruction Symptom Evaluation; 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; Q1 to Q3, quartile 1 to quartile 3; REM = rapid eye movement; TST = total sleep time.