Name
psg_avg_hypopnea_length_3p_rem
Label
Average length of each hypopnea with >= 3% oxygen desaturation in REM sleep (seconds)
Units
seconds (s)
Type
numeric
PATS Visit timepoint vs Average length of each hypopnea with >= 3% oxygen desaturation in REM sleep (seconds)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 302 13.8 ± 5.2 13.0 6.0 43.0 253 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 98 13.6 ± 5.0 12.0 6.0 30.0 193 291
Assigned treatment arm vs Average length of each hypopnea with >= 3% oxygen desaturation in REM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 161 12.5 ± 4.7 12.0 6.0 37.0 169 330
Early Adenotonsillectomy 77 12.0 ± 4.0 12.0 7.0 24.0 90 167
Watchful Waiting with Supportive Care 84 13.0 ± 5.2 12.0 6.0 37.0 79 163
Assigned treatment arm vs Average length of each hypopnea with >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 98 13.6 ± 5.0 12.0 6.0 30.0 193 291
Early Adenotonsillectomy 40 12.6 ± 5.2 10.0 7.0 28.0 107 147
Watchful Waiting with Supportive Care 58 14.3 ± 4.7 13.0 6.0 30.0 86 144
Child's sex vs Average length of each hypopnea with >= 3% oxygen desaturation in REM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 302 13.8 ± 5.2 13.0 6.0 43.0 253 555
Male 162 14.3 ± 5.7 13.0 6.0 43.0 124 286
Female 140 13.3 ± 4.5 13.0 6.0 37.0 129 269
Child's sex vs Average length of each hypopnea with >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 98 13.6 ± 5.0 12.0 6.0 30.0 193 291
Male 57 14.3 ± 5.1 13.0 7.0 28.0 88 145
Female 41 12.7 ± 4.6 12.0 6.0 30.0 105 146
Child's race vs Average length of each hypopnea with >= 3% oxygen desaturation in REM sleep (seconds)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 302 13.8 ± 5.2 13.0 6.0 43.0 253 555
American Indian/Alaska Native 2 8.5 ± 0.7 8.5 8.0 9.0 1 3
Asian 4 14.9 ± 3.4 14.7 11.0 19.4 6 10
Native Hawaiian or Other Pacific Islander - - - - - - 1 1
Black or African American 95 14.0 ± 5.1 13.8 7.0 43.0 66 161
White 185 13.7 ± 5.3 12.8 6.0 37.0 166 351
More than one race 13 15.0 ± 4.7 16.0 9.0 24.0 12 25
Unknown or not reported 3 17.3 ± 4.2 16.0 14.0 22.0 1 4
Child's race vs Average length of each hypopnea with >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM 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 >= 3% oxygen desaturation in REM sleep (seconds)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 98 13.6 ± 5.0 12.0 6.0 30.0 193 291
American Indian/Alaska Native - - - - - - 3 3
Asian 2 13.0 ± 4.2 13.0 10.0 16.0 2 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 22 14.5 ± 4.3 15.0 6.0 23.3 46 68
White 71 13.2 ± 5.2 11.0 7.0 30.0 132 203
More than one race 3 16.0 ± 5.2 13.0 13.0 22.0 9 12
Unknown or not reported - - - - - - 1 1