Sleep disruption in the ICU
Conditions
Interventions
In this pilot study, a double-blind double-dummy design will be used. One group will receive standard care i.e. temazepam 1 x 20 mg at 22:00 hr and a placebo preparation of SXB at 22.00 hr and 02.00 h
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Admission to the ICU/MCU; Expected duration of ICU/MCU admission > 2 nights after detection of sleep difficulties; Awake, conscious (patients can be intubated); RASS (Richmond Agitation-Sedation Scale) score = -2; The patient is experiencing sleep difficulties based on their own or clinical judgment as well as on a low score (<60% average score) on the Richard Campbell Sleep Questionnaire; The ICU physician intends to prescribe general sleep promoting measures as well as a benzodiazepine because of the sleep problems.
Exclusion criteria
Exclusion criteria: Use of sedatives for sleep problems (for example benzodiazepine use) in the last 3 days, except a low dose of Sufentanil (up to 2,5 µg/hr) in intubated patients since this dose is frequently needed to counteract laryngeal tube irritation; Current use of haloperidol, except a maintenance dose in patients recovering from a delirium; RASS score 3; SSADH-deficiency; Severe depression; Planned ICU admission time < 3 nights after detection of sleep difficulties.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency during the designated ICU night period between 22:00 hrs and 06:00 hrs, as determined by polysomnography (PSG) on the second study night. | — |
Secondary
| Measure | Time frame |
|---|---|
| - total sleep time, sleep fragmentation index and total amount of slow wave sleep as determined by polysomnography on the second study night; - total sleep time per night assessed by actigraphy; - incidence of delirium; - outcome parameters of patient- and nurse-derived sleep questionnaire scores (RCSQ). | — |
Contacts
Public ContactMink Schinkelshoek
Leiden University Medical Center
Outcome results
None listed