E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sleep disturbance |
Slaapverstoring |
|
E.1.1.1 | Medical condition in easily understood language |
Sleep problems |
Slaapproblemen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to promote sleep in patients suffering from sleep disruption in the ICU. |
Evalueren van de werkzaamheid van natriumoxybaat (SXB) als een medische interventie om een verstoorde nachtslaap bij patiënten op de intensive care te behandelen. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Niet van toepassing |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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Opname op de intensive care unit of medium care unit; Verwachte duur van opname op de intensive care unit of medium care unit > 2 nachten na detectie van slaapproblemen; Helder, alert (patiënten mogen geïntubeerd zijn); RASS (Richmond Agitation-Sedation Scale_ score ≥ -2; De patiënt ondervindt slaapproblemen naar de mening van patiënt zelf of het behandelteam én heeft een lage score (<60% van de gemiddelde score) op de Richard Campbell Sleep Questionnaire; De intensivist is van plan slaapbevorderende maatregelen én een benzodiazepine voor te schrijven ter behandeling van de slaapproblemen. |
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E.4 | Principal 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. |
Gebruik van sedativa voor slaapproblemen, behalve een lage dosis Sufentanil (maximaal 5 µg/uur) bij geïntubeerde patiënten, omdat deze dosis nodig is om larynxtube irritatie tegen te gaan; Gebruik van haloperidol, behalve een onderhoudsdosis in patiënten die herstellen van een delier; RASS score <-2; Actief delier, op basis van de ICDSC-NL score; SSADH-deficiëntie; Ernstige depressie; Verwachte duur van opname op de intensive care unit of medium care unit < 3 nachten na detectie van slaapproblemen. |
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E.5 End points |
E.5.1 | 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. |
Slaapefficiëntie tijdens de tweede intensive care nacht tussen 22.00 uur en 06.00 uur, gemeten middels polysomnografie (PSG). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The evaluation of this endpoint takes place during the second study night. |
Het meten van deze uitkomstmaat vindt plaats tijdens de tweede studienacht. |
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E.5.2 | 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). |
Totale slaaptijd, fragmentatie-index en totale hoeveelheid diepe slaap gemeten middels PSG; Totale slaaptijd per nacht, gemeten met actigrafie; Delierincidentie; Uitkomsten van slaapscores (RCSQ). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The evaluation of these endpoints takes place during the whole study period for one patient. |
De meting van deze uitkomstmaten vindt gedurende de gehele studieperiode van een patiënt plaats. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last study procedure of the last subject ondergoing the trial. |
De laatste studiehandeling van de laatste deelnemer van de trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |