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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004846-28-NL

Enrollment

Registered

2017-09-12

Start date

2018-11-20

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disturbance

Interventions

Trade Name: Xyrem Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use Trade Name: Temazepam Pharmaceutical Form: Tablet P

Eligibility

Sex/Gender

All

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 (=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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; Total sleep time per night assessed by actigraphy; Incidence of delirium; 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.	—

Measure

Time frame

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; Total sleep time per night assessed by actigraphy; Incidence of delirium; 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.

—

Countries

Netherlands

Contacts

Public ContactOnderzoeks Informatie Punt

Leiden University Medical Center

M.S.Schinkelshoek@lumc.nl00310715262118

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026