| Methods |
Randomised double blind cross‐over study. Randomisation procedure not described. |
| Participants |
6 pts: 2 MS and 4 SCI (3 cervical and 1 thoracic level). Length from onset not reported. Age: 29 ‐ 45 years. Inclusion criteria: Pts self reporting sleep difficulty, selected from a group of 20 receiving the infusion device. Exclusion criteria: Not described. |
| Interventions |
Intrathecal baclofen (doses ranged from 95.6 mg to 143.4 mg/day) or saline placebo infused in 2 non‐consecutive nights. One day was considered a sufficient washout time. |
| Outcomes |
Assessment performed in both study nights.
a) Polysomnographic monitoring (electroencephalogram and submental EMG; b) EMG recordings at hamstrings, quadriceps, tibialis anterior, and gastrocnemius of the worse of the two legs; c) EMG Index (EMG event/hour of sleep). EMG events were grouped according to whether they occurred before, after or without arousals or awakenings. |
| Notes |
No information on influence of quality of sleep on ADL or daytime quality of life. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Unclear |
