A comparison between temazepam and sodium oxybate to promote sleep in the intensive care unit

Phase 1

• Conditions: Sleep disturbance; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004846-28-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-12
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Use of sedatives for sleep problems, except 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 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to promote sleep in patients suffering from sleep disruption in the ICU. ;Secondary Objective: Not applicable;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: The evaluation of this endpoint takes place during the second study night.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Total sleep time, sleep fragmentation index and total amount of slow wave sleep as determined by polysomnography on the second study night; <br>Total sleep time per night assessed by actigraphy;<br>Incidence of delirium;<br>Outcome parameters of patient- and nurse-derived sleep questionnaire scores (RCSQ).;Timepoint(s) of evaluation of this end point: The evaluation of these endpoints takes place during the whole study period for one patient.