Table 2. Changes in alertness, sleep quality, psychological wellbeing, and ocular function and structure at month 3 in 46 participants who completed 3 months of sleep mask wear.
Group A (n=17) |
Group B (n=17) |
Group C (n=12) |
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Baseline (SD) range | Change at month 3 (95% CI) P-value | Baseline (SD) range | Change at month 3 (95% CI) P-value | Baseline (SD) range | Change at month 3 (95% CI) P-value | |
PVT-NL (number) | 4.53 (4.69) 0–18 | 1.96 (0.63, 3.64) 0.005a | 4.30 (5.44) 0–24 | −0.17 (−1.15, 1.11) 0.75 | 6.08 (5.42) 1–21 | −0.8 (−1.99, 1.82) 0.93 |
PVT-RT (ms) | 336.41 (36.62) 270.89–418.43 | 24.39 (13.35, 39.12) <0.001a | 332.10 (50.5) 276.1–456.6 | 25.39 (6.71, 42.34) 0.02 | 346.95 (13.37) 208–430 | 6.93 (−9.67, 23.53) 0.19 |
KSS (score) | 3.41 (1.80) 1–7 | 0.74 (−0.33, 1.86) 0.16 | 2.41 (1.12) 1–5 | 0.47 (−0.16, 1.10) 0.13 | 2.92 (1.62) 1–7 | 0.08 (−1.41, 1.58) 0.90 |
PSQ (score) | 2.65 (2.32) 0–8 | 0.82 (−0.16, 1.81) 0.09 | 3.60 (2.23) 1–9 | 0.06 (−1.23, 1.35) 0.92 | 4.58 (2.87) 1–11 | 0.5 (−0.57, 1.57) 0.32 |
CESD (score) | 4.30 (3.87) 0–16 | 1.35 (−0.52, 3.23) 0.15 | 4.20 (4.50) 0–13 | −0.88 (−3.13, 1.37) 0.42 | 6.33 (6.23) 0–20 | 1.25 (−1.92, 4.42) 0.40 |
GHQ12 (score) | 6.71 (2.02) 4–11 | 1.88 (0.51, 3.25) 0.01 | 6.94 (2.51) 3–12 | 1.47 (0.20, 2.74) 0.03 | 7.83 (2.72) 5–14 | 1.00 (0.02, 1.94) 0.046 |
BCVA (letters) | 90.65 (3.32) 85–96 | 1.59 (−0.02, 3.19) 0.05 | 89.18 (3.28) 83–95 | 1.17 (−0.10, 2.45) 0.07 | 85.92 (5.18) 79–93 | −0.33 (−2.37, 1.70) 0.73 |
CS (letters) | 41.29 (1.36) 37–42 | 0.35 (−0.37, 1.08) 0.32 | 41.18 (1.51) 36–42 | 0.17 (−0.64, 0.99) 0.65 | 35.0 (3.74) 30–41 | 1.0 (−0.67, 2.67) 0.11 |
CCT protan (u'v') | 60.29 (19.47) 22–95 | −3.41 (−12.35, 5.52) 0.43 | 61.56 (14.47) 40–86 | −7.75 (−19.93, 4.43) 0.19 | 141.64 (89.35) 42–353 | −37.14 (−90.14, 15.85) 0.15 |
CCT deutan (u'v') | 53.47 (18.57) 26–97 | 2.59 (−5.69, 10.87) 0.51 | 66.56 (19.19) 45–122 | −13.00 (−22.73, −3.27) 0.01 | 133.25 (99.47) 59–411 | −32.75 (−96.45, 30.95) 0.28 |
CCT tritan (u'v') | 64.12 (22.51) 33–106 | −2.47 (−16.02, 11.08) 0.70 | 78.06 (36.58) 29–158 | −4.06 (−28.84, 20.71) 0.73 | 233.0 (131.55) 34–488 | −46.5 (−129.3, 36.3) 0.24 |
mfERG amp 1 (μV) | 68.98 (16.02) 41.5–108 | 0.39 (−8.43, 9.21) 0.92 | 64.25 (12.22) 44.9–88.6 | 1.45 (−3.99, 6.91) 0.58 | 56.17 (9.76) 38.2–70.1 | 0.73 (−7.17, 8.65) 0.84 |
mfERG lat 1 (ms) | 35.81 (2.19) 31.5–40.2 | −1.18 (−2.14, −0.22) 0.02 | 36.25 (1.72) 33.4–39.2 | −0.29 (−1.05, 0.48) 0.44 | 38.18 (2.05) 35.4–41.3 | −0.35 (−1.33, 0.62) 0.44 |
EOG (light rise ratio) | 2.36 (0.40) 1.66–3.00 | 0.16 (−0.68, 0.99) 0.70 | 2.22 (0.42) 1.60–3.00 | 0.19 (−1.08, 1.47) 0.75 | 2.46 (0.60) 1.7–3.6 | −0.12 (−0.42, 0.18) 0.19 |
MP1 (dB) | 19.45 (1.13) 15.6–20 | 0.25 (−0.28, 0.78) 0.33 | 19.41 (1.05) 16.6–20 | −0.06 (−0.73, 0.61) 0.86 | 13.7 (3.19) 6.6–17.8 | 1.95 (−0.39, 4.29) 0.09 |
OCT CST (μm) | 274.53 (16.72) 238–308 | −0.53 (−2.60, 1.54) 0.60 | 286.53 (20.88) 255–319 | −2.82 (−5.62, −0.02) 0.05 | 320.50 (35.34) 274–389 | −6.25 (−20.40, 7.90) 0.35 |
OCT maxST (μm) | 365.33 (34.69) 327–439 | −12.00 (−28.80, 4.80) 0.14 |
Abbreviations: BCVA, best corrected visual acuity; CCT, Cambridge color vision test; CESD, The Centre for Epidemiologic Studies Depression scale; CS, contrast sensitivity; EOG, electrooculogram; GHQ12, General Health Questionnaire of psychological wellbeing; KSS, Karolinska Sleep Scale; mfERG, multifocal electroretinogram; MP1, microperimetry; OCT CST, optical coherence tomography mean central subfield thickness; OCT maxST, mean thickness of OCT subfield with maximal pathology; PSQI, Pittsburgh Sleep Quality Index; PVT-NL, psychomotor vigilance task (PVT) number of lapses; PVT-RT, PVT response time.
Data are presented as means with SD or 95% confidence intervals, corrected for hours of mask wear. P-values refer to paired t-tests of change in outcome (month 3 minus baseline), are uncorrected and should be interpreted against adjusted values of α (see text). Levels of P ≤ 0.05 are shown in bold.
Indicates statistically significant co-primary variable.