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An investigation of sleep monitoring techniques and the impact of the clinical environment on Intensive Care patients sleep.

An investigation of the application of actigraphy to assess sleep disturbance compared to polysomnography and subjective sleep assessments within the Intensive Care Unit.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000945527
Enrollment
30
Registered
2015-09-09
Start date
2017-07-07
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Sleep is an essential biological function which is required by all animal. The Intensive Care Unit (ICU) environment fails to be propitious for sleep, which has been attributed to immediate and long term physiological and psychological morbidities. It is widely acknowledge that sleep is critical for ICU patients’ recovery, however the ability to monitor and evaluate sleep amongst this patient cohort has eluded clinicians. Bio-physiological monitoring of sleep undertaken via polysomnography is not viable for widespread implementation into intensive care as it is cumbersome, expensive, technically difficult, and requires expertise in data analysis. However, identifying alternative sleep monitoring methods that are both accurate and feasible have eluded clinicians. The role of sleep is an aspect of clinical care that is imperative to address in order to improve patient health, support physiological homeostasis, and to implement strategies that mitigate the short and long term adverse effects associated with sleep disturbance that complicates patient’s recovery. This study is investigating whether sleep monitoring conducted by actigraphy will provide an accurate objective assessment of total sleep time and sleep fragmentation compared to polysomnography. Objectives: 1.To determine the total sleep time of patients admitted to ICU. 2.Evaluate the sleep architecture of patients admitted to an Australian Intensive Care Unit

Interventions

Concurrent sleep monitoring techniques applied to patients admitted to the intensive care environment, including polysomnography, actigraphy, patient self-reports and clinician based observations. Sleep monitoring procedure: Actigraphy: Participants will be fitted an omidirectional accelerometer wrist actigraphy watch, which detects movement used to identify activity/rest cycles. This device will monitoring rest/activity cycles for a 24 hour period. Polysomnography: 24 hour polysomnography w

Concurrent sleep monitoring techniques applied to patients admitted to the intensive care environment, including polysomnography, actigraphy, patient self-reports and clinician based observations. Sleep monitoring procedure: Actigraphy: Participants will be fitted an omidirectional accelerometer wrist actigraphy watch, which detects movement used to identify activity/rest cycles. This device will monitoring rest/activity cycles for a 24 hour period. Polysomnography: 24 hour polysomnography will be conducted, and requires the application of 9 small electrodes on the head and face to record the biophysiological features of the sleep cycle. Patient self-assessment:Patients will be requested to complete the Richards-Campbell Sleep Questionnaire (RCSQ) and the Karolinska Sleepiness Scale (univariant scale). The RCQS is a 6 item scale that will be completed by the patient the following morning after the night recording, whilst the Karolinska Sleepiness Scale will be completed at three intervals with minimum of 6 hours between assessments to evaluate subjective sleepines Participants who are able to complete the sleep self assessment questionnaires will be followed up in the clinical wards post ICU discharge to complete the Little Sleep Questionnaire (LSQ). This questionnaire explores patients perceived sleep quality at home compared to the ICU experience, and the factors that contributed to sleep disturbance or could have enhanced their sleep quality. Nurses subjective assessment of sleep: Nursing staff will be required to complete an hourly sleep assessment, contained within the MetaVision electronic information system (iMDSoft). This assessment will require nursing staff to subjectively assess if the participant has been awake, asleep for less than 15 minutes, asleep for approximately 30 minutes, asleep for 45 minutes, asleep approximately 60 minutes of each hour of the monitoring period, or could not assess (e.g. due to sedation). This monitoring will conducted over the 24 hour monitoring period. Monitoring of environmental factors considered to be the etiological cause of sleep disturbance; light, noise and clinical interactions.

Sponsors

Assistant Professor Lori Delaney
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Over 18 years of age. Admission to intensive care anticipated to be greater than 24 hours.

Exclusion criteria

Patients will be ineligible for the study if the treating ICU consultant determines the patient to: 1. Have significant neurological injury (Intra-cranial pressure >20mmHg in the past 24 hours, neurosurgical intervention in the past 3 days), 2. If patients are not suspected to survive for more than 24 hours, 3. Admissions with a confirmed or suspected drug overdose, 4. Patients who have been administered administered paralyzing agents within the past 24 hours, 5. Patients requiring a barbiturate infusion, 6. Patients admitted with a primary seizure disorder or assessed has having seizure activity, 7. Patients who are receiving palliative care or treatment withdrawal, 8. Patients with a known past medical history of Parkinson’s or Alzheimer’s Disease, 9. Inadequate English language skills, 10. Facial injuries that prohibit the placement of the PSG electrodes, 11. Injuries that preclude the application of actigraphy, 12. Patients with known spinal cord injury or neuromuscular dege nerative conditions such as Guillain Barrre Syndrome, and 13. Clinically suspected encephalopathies: septic encephalopathy, hepatic encephalopathy or uremic encephalopathy

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 15, 2026