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Sleep after intensive care study

Sedation, memory and sleep disturbances after intensive care: a mixed-methods study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN86243044
Enrollment
100
Registered
2025-09-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Post-intensive care syndrome (PICS), sleep disturbance, trauma symptoms, memory re-experiencing Mental and Behavioural Disorders

Interventions

Current methodology as of 12/11/2025: ICU patients will be invited to complete three questionnaires 4 weeks after discharge home. Questionnaires will ask about their ICU memories (ITQ - International
the sedated/no-sedated sub-groups will be compared using t-tests or non-parametric equivalents. Interviews will undergo reflexive thematic analysis to identify patterns in how patients describe their

Sponsors

County Durham and Darlington NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. English-speaking (to ensure language accuracy of data collection) 3. Admitted to ICU for a minimum of 72 hours (to ensure sufficient exposure to the ICU environment relevant to the study aims) 4. No longer requiring critical care (downgraded to ward-level care) 5. Expected to be discharged home within the next 7 days 6. Able to provide informed consent 7. Score negative on a CAM-ICU assessment 8. Score 15/15 on a GCS assessment For ventilated participants: 9. Must have received continuous sedation for =24 hours during ICU admission 10. Sedation depth must be confirmed by a RASS score of -3 or deeper (as documented in clinical records) 11. Must have been extubated within the ICU setting For non-sedated participants: 12. Must not have received sedation or ventilation at any point during their hospital admission. A subset of participants may be invited to take part in a one-off interview. Selection will be based on sleep symptom profiles, although matching across sedation groups may be limited due to timing and sample availability.

Exclusion criteria

Exclusion criteria: 1. Documented diagnosis of severe cognitive impairment that would affect their ability to participate meaningfully (assessed via clinical records and/or clinician judgement) 2. Currently receiving end-of-life care 3. Non-English speaking 4. Transferring to another hospital

Design outcomes

Secondary

MeasureTime frame
1. Trauma/distress symptoms identified using the International Trauma Questionnaire (ITQ) at least 2 weeks post-ICU discharge, completed once 2. ICU memories identified using the ICU- Memory Tool (ICUMT) at least 2 weeks post-ICU discharge, completed once

Primary

MeasureTime frame
Current primary outcome measure as of 12/11/2025: Sleep experience/symptoms identified using the Pittsburgh Sleep Quality Index (PSQI), at least 4 weeks post-ICU discharge, completed once Previous primary outcome measure: Sleep experience/symptoms identified using the Pittsburgh Sleep Quality Index (PSQI), at least 2 weeks post-ICU discharge, completed once

Countries

England, United Kingdom

Contacts

Public ContactSally Horsley
sally.horsley@nhs.net+44 (0)7985281075

Outcome results

None listed

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