Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial

Phase 2

Recruiting

Conditions: Slaapstoornissen
sleep disturbance
sleep problems

Registration Number: NL-OMON56249

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 38

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

Use of sedatives (dexmedetomidine, temazepam, oxazepam, propofol, midazolam)
for sleep problems except for a low dose of sufentanil (up to 5 µg/hr) in
intubated patients since this dose is frequently needed to counteract laryngeal
tube irritation;
Use of certain medication before inclusion:
- More than 1 night of temazepam use: 1 night washout before inclusion;
- Propofol: 1 night washout before inclusion;
- Midazolam: 2 nights washout before inclusion.
Current use of haloperidol, except a maintenance dose in patients recovering
from a delirium;
RASS score < -2;
Active delirium, as assessed by the ICDSC-NL score;
SSADH-deficiency;
Severe depression;
Planned ICU admission time < 3 nights after detection of sleep difficulties.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sleep efficiency during the designated ICU night period between 22:00 hrs and<br /><br>06:00 hrs, as determined by polysomnography (PSG) on the second study night. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- total sleep time, sleep fragmentation index and total amount of slow wave<br /><br>sleep as determined by polysomnography on the second study night;<br /><br>- total sleep time per night assessed by actigraphy;<br /><br>- incidence of delirium;<br /><br>- outcome parameters of patient- and nurse-derived sleep questionnaire scores<br /><br>(RCSQ);.<br /><br>- average light intensity per night;<br /><br>- average sound intensity per night;<br /><br>- arousals after sound intensity peaks;<br /><br>- Cohen*s kappa of sleep headband derived sleep scores compared with the PSG-<br /><br>derived sleep scoress.</p><br>