Table 4.
Sleep Scale | Baseline | Month 4 | Month 12 | Global P |
---|---|---|---|---|
Sleep problems index 1 | ||||
per-protocol cohort | 39 (35, 43) | 33 (29, 37) | 33 (29, 36) | 0.001 |
ITT cohort | 43 (40, 46) | 37 (34, 40) | 38 (35, 41) | <0.0001 |
Sleep problems index 2 | ||||
per-protocol cohort | 41 (37, 45) | 35 (31, 39) | 34 (31, 38) | <0.001 |
ITT cohort | 45 (42, 48) | 39 (36, 42) | 39 (36, 42) | <0.0001 |
Sleep adequacy | ||||
per-protocol cohort | 49 (44, 54) | 52 (47, 57) | 53 (49, 58) | 0.23 |
ITT cohort | 44 (41, 48) | 50 (46, 54) | 49 (46, 53) | 0.007 |
Sleep disturbances | ||||
per-protocol cohort | 43 (38, 48) | 38 (33, 43) | 36 (30, 41) | 0.004 |
ITT cohort | 47 (43, 51) | 42 (37, 46) | 40 (36, 44) | <0.0001 |
Snoring | ||||
per-protocol cohort | 44 (37, 51) | 39 (32, 46) | 37 (30, 44) | 0.08 |
ITT cohort | 46 (41, 51) | 44 (39, 49) | 44 (38, 49) | 0.4 |
Awaken short of breath or with a headache | ||||
per-protocol cohort | 17 (12, 21) | 9 (5, 13) | 12 (8, 16) | 0.002 |
ITT cohort | 18 (14, 21) | 12 (9, 15) | 14 (11, 17) | <0.001 |
Daytime somnolence | ||||
per-protocol cohort | 39 (35, 43) | 30 (26, 34) | 32 (27, 36) | 0.0001 |
ITT cohort | 44 (41, 47) | 38 (35, 42) | 39 (35, 43) | <0.0001 |
Sleep quantity (hours) | ||||
per-protocol cohort | 6.5 (6.2, 6.9) | 6.6 (6.3, 6.9) | 6.6 (6.2, 7.0) | 0.9 |
ITT cohort | 6.3 (6.0, 6.6) | 6.5 (6.2, 6.7) | 6.4 (6.2, 6.7) | 0.3 |
Optimal sleep (%) | ||||
per-protocol cohort | 42 (34, 52) | 37 (29, 47) | 38 (29, 48) | 0.7 |
ITT cohort | 37 (30, 44) | 35 (28, 43) | 35 (28, 42) | 0.9 |
The data are presented as adjusted means (95% confidence interval). The adjustment variables include use of anxiolytics and hypnotics, baseline presence of RLS, time, and interaction of time and use of medications. The per-protocol analysis includes 127 participants, and the ITT analysis includes 235 participants. The global P values are based on testing time (baseline, month 4, and month 12) as a fixed effect from repeated measures analysis of covariance. P ≤ 0.05 for pair-wise comparisons of baseline versus month 4 and month 12 for individual components of the MOS sleep survey (both per-protocol and ITT cohort), with the exception of the snoring scale, sleep quantity, and optimal sleep comparisons of baseline versus month 4 and month 12.