Skip to content

Development of a perioperative ActiGraph actigraphic sleep monitoring algorithm: secondary analysis of a randomized controlled trial

Development of a perioperative ActiGraph actigraphic sleep monitoring algorithm: secondary analysis of a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093285
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-02
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Perioperative.sleep disorder

Interventions

Observation group:None

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: This study was a secondary analysis of a previous randomized controlled trial (RCT) study, and the patient inclusion criteria were consistent with the previous RCT study. That is, all cases in the original database met the inclusion criteria. The inclusion criteria were: (1) Age 18-80 years; (2) Preoperative STOP-BANG score =3 and HCO3- =28 mmol/L without regular CPAP treatment; (3) Intended to undergo non-cardiac, non-specialized surgery under general anesthesia, with an estimated operative time of =1h, and postoperative use of patient-controlled intravenous analgesia.

Exclusion criteria

Exclusion criteria: Patients whose PSG and Actigraphy data records were not available in the original database were excluded and the remaining data were included in the analysis. Anyone with one of the following conditions was excluded as an enrolled case: (1) Previously diagnosed central sleep apnea; (2) Severe central nervous system disorders (stroke, epilepsy, intracranial tumors, Parkinson's, craniocerebral trauma) and neuromuscular disorders (myasthenia gravis); (3) History of schizophrenia or history of mental illness within 3 months or current use of antipsychotic medications (including antidepressants, anxiolytics); (4) Inability to complete preoperative evaluation due to severe cognitive impairment (e.g., dementia, Alzheimer's) or hearing impairment; (5) Have a history of drug or alcohol dependence or have taken sedative/hypnotic medications within 1 month; (6) Presence of contraindications to transnasal high-flow oxygen therapy (mediastinal emphysema, hypotension or shock, cerebrospinal fluid leakage, acute otitis media, rhinitis, uncontrolled sinusitis infection, deviated septum, glaucoma); (7) Severe bronchial or pulmonary disease (pulmonary bullae, pneumothorax, recent tracheal fistula); (8) Pathological sinus node syndrome, severe bradycardia (heart rate class III or LVEF < 30%, liver function Child-Pugh classification C, preoperative dialysis treatment, ASA classification = class IV, or expected survival = 24 hours); (10) Preoperative use of (continuous positive airway pressure, CPAP) or transnasal high-flow oxygen therapy; (11) Anticipated need for postoperative ICU admission with tracheal intubation; (12) Refusal to participate in this study; (13) Other conditions that the investigator considers inappropriate for participation in this study.

Design outcomes

Primary

MeasureTime frame
the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;

Secondary

MeasureTime frame
the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;the epoch-by-epoch sensitivity of actigraphy in predicting sleep-wake status;the epoch-by-epoch specificity of actigraphy in predicting sleep-wake status;

Countries

China

Contacts

Public ContactHuai-Jin Li

Peking University First Hospital

crystal_35@163.com+86 10 8357 5138

Outcome results

None listed

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