Name
psg_avg_hypopnea_length_4p_nrem
Label
Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Units
seconds (s)
Type
numeric
PATS Visit timepoint vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 224 14.3 ± 6.0 13.0 5.0 46.0 331 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 61 13.4 ± 4.9 14.0 5.0 30.0 230 291
Assigned treatment arm vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 89 13.1 ± 6.1 11.0 6.0 37.0 241 330
Early Adenotonsillectomy 41 12.6 ± 4.8 11.0 6.0 26.0 126 167
Watchful Waiting with Supportive Care 48 13.5 ± 7.1 11.0 6.0 37.0 115 163
Assigned treatment arm vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 330 330
Early Adenotonsillectomy - - - - - - 167 167
Watchful Waiting with Supportive Care - - - - - - 163 163
Assigned treatment arm vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
Early Adenotonsillectomy - - - - - - 140 140
Watchful Waiting with Supportive Care - - - - - - 143 143
Assigned treatment arm vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 61 13.4 ± 4.9 14.0 5.0 30.0 230 291
Early Adenotonsillectomy 26 12.1 ± 4.2 11.0 5.0 22.0 121 147
Watchful Waiting with Supportive Care 35 14.4 ± 5.2 14.0 6.0 30.0 109 144
Child's sex vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 224 14.3 ± 6.0 13.0 5.0 46.0 331 555
Male 122 14.8 ± 6.4 13.5 6.0 46.0 164 286
Female 102 13.8 ± 5.6 13.0 5.0 40.5 167 269
Child's sex vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
Male - - - - - - 162 162
Female - - - - - - 170 170
Child's sex vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
Male - - - - - - 137 137
Female - - - - - - 146 146
Child's sex vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 61 13.4 ± 4.9 14.0 5.0 30.0 230 291
Male 37 13.8 ± 5.0 14.0 7.0 30.0 108 145
Female 24 12.8 ± 4.8 11.0 5.0 27.0 122 146
Child's race vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 224 14.3 ± 6.0 13.0 5.0 46.0 331 555
American Indian/Alaska Native 1 11.0 - 11.0 11.0 11.0 2 3
Asian 3 14.5 ± 6.3 14.0 8.4 21.0 7 10
Native Hawaiian or Other Pacific Islander 1 17.7 - 17.7 17.7 17.7 - 1
Black or African American 74 14.6 ± 6.1 13.5 5.0 40.5 87 161
White 132 14.0 ± 5.6 13.0 6.0 37.0 219 351
More than one race 10 13.4 ± 3.7 11.5 10.0 21.0 15 25
Unknown or not reported 3 22.9 ± 20.2 13.7 9.0 46.0 1 4
Child's race vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 6 6
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American - - - - - - 73 73
White - - - - - - 235 235
More than one race - - - - - - 14 14
Unknown or not reported - - - - - - 1 1
Child's race vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 4 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American - - - - - - 64 64
White - - - - - - 200 200
More than one race - - - - - - 12 12
Unknown or not reported - - - - - - - -
Child's race vs Average length of each hypopnea with >= 4% oxygen desaturation in NREM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 61 13.4 ± 4.9 14.0 5.0 30.0 230 291
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 4 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 23 12.6 ± 4.5 14.0 5.0 22.0 45 68
White 34 13.9 ± 5.3 14.0 8.0 30.0 169 203
More than one race 4 14.0 ± 3.6 13.5 11.0 18.0 8 12
Unknown or not reported - - - - - - 1 1