Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB : 2025-A00224-45 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.
Sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. Consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery.
Current management of these disorders remains limited:
In this context, the Richards-Campbell questionnaire (RCSQ) represents an interesting alternative for subjectively assessing sleep in intensive care patients. This questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. The validation of a French version of the RCSQ meets a need to standardise assessment practices in France and to gain a better understanding of the factors influencing sleep quality in intensive care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ) in french version | Diagnostic Test | The RCSQ questionnaire translated into French (RCSQ-F) will be distributed to intensive care patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study. The questionnaire will be distributed on two occasions: at the first visit and on the day of discharge from intensive care for survivors, or at the latest on the 14th day of hospitalisation. Patients' use of the questionnaire will enable internal validation (primary objective) by exploratory factor analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the French translation of the Richards-Campbell questionnaire | Assessing the internal validity of the French translation of the Richards-Campbell questionnaire for analysing sleep quality in intensive care patients | Visit Inclusion (V1, Day 1) and Visit V2 (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-rater agreement between patients and nurses | Evaluation of inter-rater agreement between scores given by patients and nurses. The inter-judge agreement between patient and nurse (first secondary objective) will be evaluated by an intra-class correlation coefficient (single measure, absolute agreement, two-way random) on observations with neither missing data on the patient assessment nor the nurse assessment at the V1 visit. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The RCSQ-F questionnaire will be distributed at the same time as the ISI and Epworth questionnaires to ICU patients who meet the inclusion and non-inclusion criteria and who have given their informed consent to participate in the study.
The questionnaires will be distributed on two occasions: at the first visit and on the day of discharge from intensive care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie-Anne MM MELONE, Doctor | University Rouen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Poitiers | Poitiers | 86021 | France | |||
| University Rouen Hospital |
The data provided will be the property of the sponsor and will be used solely for its own research activities.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Visit Inclusion (V1, Day 1) |
| Convergent validity of the results of the French RCSQ with other questionnaires | To assess the convergent validity of the results of the French RCSQ with the Epworth scale. This convergent validity (2nd secondary objective) will be assessed by the Pearson correlation coefficient of the overall score of the RCSQ-F with the Epworth on observations with no missing data on these scales at the V1 visit. | Visit Inclusion (V1, Day 1) |
| Convergent validity of the results of the French RCSQ with other questionnaires | To assess the convergent validity of the results of the French RCSQ with the ISI scale. This convergent validity (2nd secondary objective) will be assessed by the Pearson correlation coefficient of the overall score of the RCSQ-F with the ISI on observations with no missing data on these scales at the V1 visit. | Visit Inclusion (V1, Day 1) |
| Divergent validity of results | Assess the divergent validity of the results by analysing the correlation between the French RCSQ and the HAD scale. This divergent validity will be assessed at V1 by calculating the Pearson correlation coefficient between the total RCSQ-F and the HAD scale: a low correlation coefficient (but not necessarily zero) is desirable: R < 0.30 ideally. | Visit Inclusion (V1, Day 1) |
| French RCSQ's sensitivity to change | To assess the sensitivity to change of the French RCSQ by analysis of subjects with neither missing data at V1 nor missing data at V2 (discharge from intensive care) concerning the RCSQ-F. Sensitivity to change will be assessed by a 95% Student's confidence interval on paired series estimating the difference in standardised means (i.e. divided by the standard deviation at V1) of the total RCSQ-F. The sensitivity to change of each of the RCSQ-F items will be analysed in the same way. The correlation matrix of changes in the items between V1 and V2 will also be calculated, thus verifying the consistency of the evolutionary trends. | Visit V2 (Day 14) |
| Rouen |
| 76031 |
| France |