Table 1.
Baseline characteristics across treatment sequence
| Treatment sequence | |||
|---|---|---|---|
| TBI characteristics | Melatonin then placebo (n = 18) | Placebo then melatonin (n = 15) | Overall (n = 33) |
| Age, mean (SD), years | 35 (11) | 38 (11) | 37 (11) |
| Body mass index, mean (SD), kg/m2 | 25.5 (3.7) | 26.1 (4.1) | 25.7 (3.8) |
| Males, no. (%) | 11 (61) | 11 (73) | 22 (67) |
| Paid employment, no. (%)a | 4 (22) | 3 (20) | 7 (21) |
| Months post-injury, median (IQR Q1–Q3) | 61 (28–115) | 25 (10–72) | 46 (13–102) |
| Lowest GCS, median (IQR Q1–Q3), raw value | 5 (3–9) | 8 (3–13) | 6 (3–12) |
| PTA duration, median (IQR Q1–Q3), days | 21 (12–45) | 41 (27–60) | 33 (13–47) |
| Mild TBI, no. (%), PTA 0 to ≤ 1 day | – | 2 (13) | 2 (6) |
| Moderate TBI, no. (%), PTA >1 to ≤ 7 days | 2 (11) | 1 (7) | 3 (9) |
| Severe TBI, no. (%), PTA > 7 days | 16 (89) | 12 (80) | 28 (85) |
| Patients prescribed medication, no. (%) | 13 (72) | 6 (40) | 19 (58) |
| Patients using analgesics, no. (%) | 7 (38) | 2 (13) | 9 (27) |
| Patients using antacids, no. (%) | 1 (6) | 1 (7) | 2 (6) |
| Patients using antidepressants, no. (%) | 6 (33) | 2 (13) | 8 (24) |
| Patients using antiepileptics, no. (%) | 4 (22) | 3 (20) | 7 (21) |
| Patients using multivitamins, no. (%) | 1 (6) | 1 (7) | 2 (6) |
| Patients using NSAIDs, no. | 1 (6) | 2 (13) | 3 (9) |
| PSQI, global score | 10 (3) | 12 (4) | 11 (3) |
| Sleep latency, minimum, median (IQR Q1–Q3) | 25 (15–55) | 23 (13–52) | 24 (14–52) |
| Sleep efficiency, %, (IQR Q1–Q3) | 76 (82–86) | 81 (71–83) | 81 (75–83) |
| ESS, score | 7 (4) | 9 (5) | 8 (5) |
| HADS anxiety | 8 (4) | 8 (5) | 8 (4) |
| HADS depression | 11 (6) | 8 (6) | 10 (6) |
| FSS, score, median (IQR Q1–Q3) | 48 (39–56) | 49 (42–59) | 49 (41–57) |
| SF-36 v1 | |||
| Physical functioning (PF), score | 36 (16) | 42 (13) | 38 (15) |
| Role physical (RP), score | 39 (14) | 38 (12) | 38 (13) |
| Role emotional (RE), score | 38 (15) | 41 (11) | 39 (13) |
| Vitality (VT), score | 39 (9) | 37 (10) | 38 (9) |
| Mental health (MH), score | 40 (13) | 40 (9) | 40 (11) |
| Social functioning (SF), score | 38 (12) | 35 (14) | 37 (13) |
| Bodily pain (BP), score | 44 (14) | 40 (12) | 42 (13) |
| General health (GH), score | 42 (11) | 39 (15) | 40 (13) |
ESS Epworth Sleepiness Scale, FSS Fatigue severity scale, GCS Glasgow coma scale, HADS Hospital Anxiety Depression Scale, IQR inter-quartile range, PSQI Pittsburgh Sleep Quality Index, NSAID nonsteroidal anti-inflammatory drug, PTA Post-traumatic amnesia, SF-36 v1 Short-form health survey, TBI traumatic brain injury
aPaid employment reflects part-time and full-time employment