Introduction
Materials and methods
Study design
Study participants
Baseline assessments
Study protocol: effects of NHF at nighttime
Study protocol: effects of NHF during daytime
Noninvasive hemodynamic monitoring
Statistical analysis
Results
Patients (n = 12) | |
---|---|
Male, n (%) | 5 (41.7) |
Age, years | 68.4 ± 11.1 |
BMI, kg/m² | 30.5 ± 3.5 |
BSA, m2 | 2.0 ± 0.2 |
NYHA class I, n (%) | 1 (8.3) |
NYHA class II, n (%) | 7 (58.3) |
NYHA class III, n (%) | 3 (25) |
NYHA class IV, n (%) | 1 (8.3) |
LVEF, % | 60.9 ± 7.0 |
Impaired LVEF, n (%) | 0 (0) |
RVEF, % | 53.5 ± 12.0 |
Impaired RVEF, n (%) | 3 (30) |
AHI, /h | 21.5 (12.2–46.2) |
AHI > 10/h, n (%) | 12 (100) |
AI, /h | 8.2 (1.5–19.7) |
cAI, /h | 0.6 (0.0–6.8) |
oAI, /h | 4.5 (1.4–12.3) |
HI, /h | 11.5 (4.2–26.4) |
T < 90%, min | 166.2 ± 102.1 |
Minimum oxygen saturation, % | 72.4 ± 10.4 |
Mean oxygen saturation, % | 89.6 ± 2.7 |
tcCO2, mmHg | 39.2 ± 5.8 |
ODI, /h | 14.4 (10.8-32.2) |
Medication, n (%) | 10 (83.3) |
Phosphodiesterase inhibitor | 5 (41.7) |
Direct cyclic guanylate cyclase stimulator | 3 (25) |
Endothelin receptor antagonist | 5 (41.7) |
Prostacyclin analog | 0 (0) |
Impact of NHF20 on sympathovagal balance, sleep, and sleep apnea
No treatment (n = 12) | NHF20 (n = 12) | P value+ | NHF50 (n = 6) | P value+ | APAP (n = 12) | P value+ | |
---|---|---|---|---|---|---|---|
Sympathovagal balance parameters | |||||||
HFnuRRI, % | 52.8 ± 25.2 | 60.1 ± 23.7 | 0.005 | 61.0 ± 21.4 | 0.362 | 59.6 ± 20.4 | 0.079 |
LFnuRRI, % | 47.2 ± 25.2 | 39.9 ± 23.7 | 0.005 | 39.1 ± 21.4 | 0.362 | 40.5 ± 20.4 | 0.079 |
LF/HF nu RRI | 1.7 ± 2.1 | 1.0 ± 1.0 | 0.009 | 0.9 ± 0.8 | 0.193 | 1.0 ± 1.0 | 0.034 |
HFnudBPV, % | 21.0 ± 8.1 | 15.4 ± 8.1 | 0.028 | 17.9 ± 4.5 | 0.094 | 13.6 ± 8.0 | 0.004 |
LFnudBPV, % | 32.2 ± 10.4 | 28.2 ± 11.6 | 0.247 | 34.1 ± 6.6 | 0.290 | 33.0 ± 13.5 | 0.846 |
LF/HF nu dBPV | 1.8 ± 1.1 | 2.3 ± 1.7 | 0.129 | 2.0 ± 0.7 | 0.355 | 3.3 ± 2.7 | 0.060 |
BRS slope* | |||||||
Up event counts | 19.0 (17.0-26.0) | 21.0 (17.0-39.0) | 0.637 | 11.0 (9.3-12.8) | 0.037 | 16.0 (8.0-24.0) | 0.389 |
Up events, ms/mmHg | 6.0 (5.6-14.4) | 8.2 (5.9-14.5) | 0.570 | 14.5 (9.3-27.6) | 0.923 | 13.4 (4.6-17.7) | 0.652 |
Down event count | 17.5 (16.3-30.3) | 25.0 (11.3-28.0) | 0.978 | 7.0 (6.0-13.0) | 0.248 | 18.0 (7.8-24.0) | 0.622 |
Down events, ms/mmHg | 7.6 (5.9-13.4) | 8.7 (7.5-12.1) | 0.557 | 11.0 (4.2-12.4) | 0.862 | 10.7 (5.7-17.1) | 0.084 |
Hemodynamic parameters | |||||||
Heart rate, min−1 | 69.7 ± 9.7 | 65.9 ± 9.4 | 0.021 | 64.3 ± 12.2 | 0.155 | 66.5 ± 9.0 | 0.001 |
Systolic BP, mmHg | 105.9 ± 13.3 | 99.8 ± 8.7 | 0.242 | 104.9 ± 14.9 | 0.687 | 106.8 ± 10.4 | 0.865 |
Diastolic BP, mmHg | 61.5 ± 12.1 | 59.7 ± 7.0 | 0.655 | 62.6 ± 6.0 | 0.730 | 62.9 ± 9.8 | 0.746 |
Stroke volume index, mL/m² | 25.7 ± 5.0 | 24.9 ± 4.5 | 0.164 | 23.3 ± 3.5 | 0.391 | 26.5 ± 5.3 | 0.910 |
Cardiac index, L/min/ m² | 1.8 ± 0.4 | 1.6 ± 0.4 | 0.165 | 1.5 ± 0.4 | 0.191 | 1.8 ± 0.4 | 0.193 |
TPRI, dyne·s m² cm−5 | 3680.9 ± 1198.6 | 3808.8 ± 1133.4 | 0.412 | 4233.5 ± 660.0 | 0.674 | 3794.3 ± 1106.1 | 0.204 |
Respiratory parameters | |||||||
Mean SpO2, % | 90.5 ± 3.3 | 91.0 ± 2.3 | 0.324 | 92.0 ± 1.9 | 0.586 | 91.5 ± 2.7 | 0.349 |
tcCO2, mmHg** | 38.5 ± 3.7° | 39.0 ± 4.6° | 0.384 | 39.6 ± 5.8 | 0.650 | 38.1 ± 5.7° | 0.641 |
No treatment (n = 12) | NHF20 (n = 12) | P value+ | NHF50 (n = 6) | P value+ | APAP (n = 12) | P value+ | |
---|---|---|---|---|---|---|---|
Duration of intervention, min (%TIB of the entire night) | 136.8 ± 35.1 (30.3 ± 7.8) | 130.2 ± 36.8 (28.7 ± 7.5) | 0.569 (0.569) | 87.2 ± 30.2 (19.5 ± 6.2) | 0.142 (0.135) | 133.2 ± 47.2 (29.4 ± 10.0) | 0.856 (0.837) |
Duration asleep (TST), min (% TIB of the intervention period) | 69.5 (54.9–96.6) (58.4 ± 19.4) | 83.0 (71.3–92.6) (65.4 ± 15.5) | 0.266 (0.075) | 45.5 (27.8–62.9) (52.6 ± 25.3) | 0.069 (0.060) | 71.0 (56.3–93.5) (58.0 ± 21.1) | 0.770 (0.953) |
Supine (% TST) | 76.8 (31.9–100.0) | 97.6 (49.0–100.0) | 0.313 | 56.7 (12.7–91.2) | 0.500 | 85.0 (50.9–100.0) | 0.520 |
Sleep | |||||||
Awake, min (% of the intervention period) | 51.5 (39.1–81.8) (48.4 (29.8–56.8)) | 41.8 (30.5–65.9) (32.2 (23.7–45.8)) | 0.077 (0.061) | 37.8 (26.6–56.4) (47.3 (37.5–65.1))) | 0.985 (0.060) | 60.0 (33.1–79.8) (40.2 (29.3–53.5)) | 0.869 (0.953) |
TST, min (% of the intervention period) | 69.5 (54.9–96.6) (58.4 ± 19.4) | 83.0 (71.3–92.6) (65.4 ± 15.5) | 0.266 (0.075) | 45.5 (27.8–62.9) (52.6 ± 25.3) | 0.069 (0.060) | 71.0 (56.3–93.5) (58.0 ± 21.1) | 0.770 (0.953) |
N1, min (% of the intervention period) | 8.8 (7.3–14.1) (13.6 (7.7–23.0)) | 6.3 (4.5–10.8) (7.7 (5.8–11.1)) | 0.004 (0.005) | 5.0 (3.1–6.1) (11.9 (8.4–14.2)) | 0.127 (0.902) | 8.5 (4.8–14.4) (9.4 (6.7–19.8)) | 0.466 (0.296) |
N2, min (% of the intervention period) | 36.0 (25.0–53.4) (53.1 (37.4–60.9)) | 46.5 (34.0–59.4) (60.5 (48.7–69.0)) | 0.233 (0.487) | 20.3 (14.0–31.0) (55.9 (33.2–60.3)) | 0.057 (0.837) | 40.5 (29.8–52.1) (55.1 (43.1–75.4)) | 0.813 (0.469) |
N3, min (% of the intervention period) | 11.3 (0.8–29.5) (18.4 (1.6–42.5)) | 14.3 (8.5–24.0) (22.9 (11.3–28.8)) | 0.610 (0.809) | 0.0 (0.0–13.9) (0.0 (0.0–22.7)) | 0.313 (0.540) | 14.0 (0.8–24.1) (15.4 (3.5–28.4)) | 0.610 (0.673) |
REM, min (% of the intervention period) | 0.5 (0.0–15.3) (0.9 (0.0–15.8)) | 10.3 (0.0–17.8) (10.7 (0.0–20.1)) | 0.668 (0.436) | 4.8 (0.0–10.3) (15.9 (0.0–33.5)) | 0.445 (0.295) | 0.0 (0.0–10.0) (0.0 (0.0–8.9)) | 0.859 (0.806) |
Sleep efficiency, % | 58.3 ± 19.6 | 65.4 ± 15.5 | 0.076 | 52.6 ± 25.3 | 0.059 | 57.8 ± 21.0 | 0.941 |
Arousal index, /h | 19.0 (12.3–30.0) | 17.4 (14.8–25.2) | 0.981 | 10.3 (6.5–14.6) | 0.438 | 17.5 (10.1–22.8) | 0.453 |
Respiratory-related arousals, /h | 5.7 (2.7–14.3) | 11.1 (7.8–13.9) | 0.580 | 2.8 (0.5–23.1) | 0.604 | 3.9 (2.0–13.0) | 0.325 |
PLM-related arousals, /h | 5.4 (0.0–16.1) | 0.7 (0.0–6.2) | 0.098 | 3.5 (0.0–8.4) | 0.810 | 0.6 (0.0–5.2) | 0.149 |
Sleep-related breathing | |||||||
AHI, /h | 20.8 (9.6–38.4) | 28.5 (17.0–46.8) | 0.465 | 6.5 (2.4–49.0) | 0.741 | 6.3 (4.9–32.4) | 0.254 |
AI, /h | 6.9 (0.9–19.4) | 1.1 (0.5–7.1) | 0.667 | 2.4 (0.2–12.7) | 0.687 | 0.5 (0.0–22.5) | 0.557 |
cAI, /h | 0.0 (0.0–0.3) | 0.0 (0.0–0.1) | 0.813 | 1.9 (0.0–7.6) | 0.138 | 0.4 (0.0–9.0) | 0.156 |
oAI, /h | 6.9 (0.5–14.0) | 0.6 (0.0–2.4) | 0.266 | 0.0 (0.0–5.0) | 0.125 | 0.0 (0.0–3.1) | 0.322 |
HI, /h | 9.2 (6.6–17.7) | 19.7 (3.4–30.9) | 0.094 | 4.2 (2.2–28.0) | 0.788 | 4.0 (0.0–10.1) | 0.097 |
Mean oxygen saturation | 88.4 ± 3.8 | 89.0 ± 2.8 | 0.455 | 90.5 ± 1.9 | 0.718 | 90.9 ± 2.5 | 0.004 |
Time with oxygen saturation < 90%, min | 56.1 (18.9–79.6) | 39.5 (24.7–69.8) | 1.000 | 8.9 (5.8–53.6) | 0.405 | 15.0 (5.6–31.5) | 0.044 |
Minimum oxygen, % | 79.9 ± 7.5 | 76.3 ± 11.5 | 0.733 | 84.3 ± 6.1 | 0.684 | 83.7 ± 4.7 | 0.151 |
ODI, /h | 10.2 (6.2–17.5) | 21.5 (11.0–31.0) | 0.239 | 4.7 (0.5–24.8) | 0.857 | 4.8 (2.4–17.3) | 0.347 |
tcCO2, mmHg* | 39.9 ± 6.2 | 40.1 ± 6.6 | 0.662 | 42.3 ± 8.4 | 0.417 | 38.1 ± 4.9 | 0.176 |