Clin Mol Hepatol > Volume 25(2); 2019 > Article |
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Values are presented as mean±standard deviation unless otherwise indicated.
NASH, nonalcoholic steatohepatitis; HBV, hepatitis B virus; HCV, hepatitis C virus; BMI, body mass index; Hb, hemoglobin; TLC, total leukocyte count; INR, International Normalized Ratio; CTP, Child-Turcotte-Pugh; MELD, model for end-stage liver disease; Art. NH3, arterial ammonia.
Parameters | Zolpidem (n=26) | Placebo (n=26) | P-value |
---|---|---|---|
Measures of minimal hepatic encephalopathy | |||
CFF (Hz) | 39.2 (33.6–42.6) | 39.7 (32.8–43.0) | 0.647 |
CFF <39 Hz (n, %) | 13 (50) | 10 (38.5) | 0.577 |
Sleep quality | |||
PSQI score | 14.0 (8.0–18.0) | 14.0 (10.0–16.0) | 0.701 |
Day-time sleepiness | |||
ESS score | 6.5 (0.0–18.0) | 6.5 (0.0–16.0) | 0.242 |
ESS score >10 (n, %) | 3 (11.5) | 4 (15.3) | 0.684 |
Polysomnography | |||
Overall sleep quality | |||
TRT (min) | 335.8 (173.5–961.0) | 328.4 (159.3–495.4) | 0.080 |
TST (min) | 245.5 (120.3–370.5) | 251.8 (123.3–365.5) | 0.833 |
SE (%) | 68.4 (19.8–87.9) | 69.8 (19.9–90.7) | 0.456 |
Sleep initiation and maintenance | |||
Sleep Lat (min) | 65.3 (35.2–180.3) | 65.4 (30.2–120.5) | 0.464 |
Arousals (/h) | 3.0 (2.0–3.0) | 3.0 (0.0–3.0) | 0.152 |
Wake* (min) | 108.9 (34.5–676.5) | 98.5 (35.6–456.8) | 0.767 |
PLMS (/h) | 29.6 (0.0–179.0) | 27.3 (0.0–151.0) | 0.365 |
Sleep architecture | |||
REM Lat (min) | 110.3 (56.0–189.5) | 103.3 (53.4–154.0) | 0.589 |
Sleep time in stage 1 (%) | 15.9 (1.1–43.6) | 15.8 (1.4–60.0) | 0.667 |
Sleep time in stage 2 (%) | 46.7 (13.0–71.6) | 37.7 (3.7–67.3) | 0.094 |
Sleep time in stage 3+4 (%) | 15.2 (2.4–50.2) | 26.7 (0.7–53.7) | 0.126 |
Sleep time in REM (%) | 10.0 (1.6–49.2) | 14.2 (0.8–64.2) | 0.146 |
Indices of apnea-hypopnea | |||
AHI (events/h) | 0.7 (0.0–3.7) | 0.9 (0.0–5.0) | 0.134 |
AHI >5/h (n, %) | 0 (0) | 0 (0) | 1.000 |
OSA (n, %) | 0 (0) | 0 (0) | 1.000 |
Mean SpO2 (%) | 95.5 (88.0–99.0) | 95.2 (90.0–98.0) | 0.352 |
Nadir SpO2 (%) | 90.0 (83.0–95.0) | 90.5 (81.5–94.0) | 0.534 |
Values are presented as median (range) unless otherwise indicated.
CFF, critical flicker frequency; PSQI, Pittsburgh sleep quality index; ESS, Epworth Sleepiness Scale; TRT, total recording time; TST, total sleep time; SE, sleep efficiency; Sleep Lat, latency to sleep onset; PLMS, periodic limbs movements of sleep; REM Lat, rapid eye movement sleep latency; AHI, apnea-hypopnea index; OSA, obstructive sleep apnea; SpO2, oxy-hemoglobin saturation; Nadir SpO2, minimal oxy-hemoglobin saturation.
Parameters | Zolpidem (n=23) | Placebo (n=24) | P1 value† | P2 value‡ | P3 value§ |
---|---|---|---|---|---|
Polysomnography | |||||
Overall sleep quality | |||||
TRT (min) | 450.5 (235.0–630.5) | 288.9 (93.3–483.0) | <0.001 | 0.078 | 0.511 |
TST (min) | 370.3 (180.0–435.5) | 200.4 (70.5–438.5) | <0.001 | <0.001 | 0.440 |
SE (%) | 78.9 (60.0–92.2) | 68.9 (10.8–227.8) | 0.006 | <0.001 | 1.000 |
Sleep initiation and maintenance | |||||
Sleep Lat (min) | 30.5 (15.0–125.3) | 71.4 (15.4–110.4) | 0.001 | <0.001 | 0.943 |
Arousals (/h) | 1.0 (0.0–3.0) | 3.0 (1.0–3.0) | <0.001 | <0.001 | 0.942 |
Wake* (min) | 82.6 (30.3–231.4) | 74.7 (20.4–130.0) | 0.125 | 0.052 | 0.909 |
PLMS (/h) | 6.8 (0.0–105.5) | 26.5 (0.0–140.5) | 0.001 | 0.028 | 0.131 |
Sleep architecture | |||||
REM Lat (min) | 90.4 (64.5–134.2) | 95.4 (64.3–144.3) | 0.873 | 0.230 | 0.063 |
Sleep time in stage 1 (%) | 12.3 (1.4–36.3) | 15.9 (2.2–67.0) | 0.489 | 0.301 | 0.219 |
Sleep time in stage 2 (%) | 46.6 (13.0–71.6) | 37.9 (6.1–68.1) | 0.167 | 0.548 | 0.841 |
Sleep time in stage 3+4 (%) | 17.0 (0.0–58.5) | 25.8 (0.0–61.7) | 0.338 | 0.784 | 0.819 |
Sleep time in REM (%) | 15.2 (2.4–50.2) | 10.8 (1.2–56.3) | 0.307 | 0.131 | 0.204 |
Indices of apnea-hypopnea | |||||
AHI (events/h) | 0.8 (0.0–3.8) | 0.9 (0.3–6.6) | 0.334 | 0.519 | 0.875 |
Mean SpO2 (%) | 96.0 (91.0–99.0) | 95.0 (91.0–99.0) | 0.122 | 0.981 | 0.138 |
Nadir SpO2 (%) | 90.0 (83.0–95.0) | 87.0 (75.0–95.0) | 0.248 | 0.711 | 0.441 |
Minimal hepatic encephalopathy | |||||
CFF (Hz) | 38.4 (33.4–40.6) | 38.8 (31.4–42.6) | 0.647 | 0.031 | 0.394 |
CFF <39 Hz (n, %) | 15 (65.2) | 14 (58.3) | 0.746 | 0.375 | 0.219 |
Art. NH3 (µg/dL) (mean±standard deviation) | 95.6±16.7 | 103.1±32.6 | 0.509 | 0.939 | 0.274 |
Sleep quality score | |||||
PSQI score | 11.0 (7.0–18) | 14.0 (10.0–16.0) | 0.009 | 0.004 | 0.682 |
% change in PQSI score | -21.4 (-50 to +20) | 0.0 (-40 to +30) | 0.024 | NA | NA |
>20% improvement in PSQI score (n, %) | 13 (56.5) | 3 (12.5) | 0.002 | NA | NA |
Day-time sleepiness | |||||
ESS score | 6.5 (0.0–18.0) | 6.5 (0.0–16.0) | 0.067 | 0.098 | 0.095 |
Values are presented as median (range) unless otherwise indicated.
TRT, total recording time; TST, total sleep time; SE, sleep efficiency; Sleep Lat, latency to sleep onset; PLMS, periodic limbs movements of sleep; REM Lat, rapid eye movement sleep latency; AHI, apnea-hypopnea index; SpO2, oxy-hemoglobin saturation; Nadir SpO2, minimal oxy-hemoglobin saturation; CFF, critical flicker frequency; Art. NH3, arterial ammonia; PSQI, Pittsburgh sleep quality index; ESS, Epworth Sleepiness Scale; NA, not applicable.
NASH, nonalcoholic steatohepatitis; BMI, body mass index; Hb, hemoglobin; AST, aspartate aminotransferase; ALT, alanine aminotransferase; INR, International Normalized Ratio; CTP, Child-Turcotte-Pugh; MELD, model for end-stage liver disease; TSH, thyroid stimulating hormone; Art. NH3, arterial ammonia; CFF, critical flicker frequency.
Manoj Kumar Sharma
https://orcid.org/0000-0003-3448-8334