Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)

NCT02302560 | Withdrawn

• 1 other identifier: TepSo
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.

Conditions

Sleep Architecture

Outcome Measures

Primary Outcomes (1)

• Changes in prevalence of rapid eye movement sleep

  Changes in prevalence of rapid eye movement (REM) sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).

  Up to 36 hours

Secondary Outcomes (18)

• Insomnia Severity Index

  Up to 90 days after the operation

• Malnutrition

  Up to 90 days after the operation

• Epsworth Sleepiness Scale

  Up to 90 days after the operation

• Postoperative Cognitive Dysfunction

  Up to 90 days after the operation

• Depth of anesthesia

  At time of surgery

Other Outcomes (4)

• Tissue Inhibitor of Metalloproteinases

  At time of spinal anesthesia

• Metalloproteinases

  At time of spinal anesthesia

• ASA (physical status classification system) status

  At the beginning of the investigation

Study Arms (1)

Patients with elective hip surgery

Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses).

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with elective hip surgery (implementation or replacement of hip joint endoprothesis)

You may qualify if:

• Male and female patients with age 50 years and above
• Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin

You may not qualify if:

• Lacking willingness to save and hand out data within the study
• Missing informed consent of the patient
• Patients with diagnosed and treated sleep disorders
• Patients with psychiatric diseases
• Patients with injuries or operations of the enteral tract and the esophagus respectively in the last four weeks before the hip surgery
• Allergies to any substance of the electrode fixing material
• Dermatoses in the area of the electrodes to be fixed

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Berlin

Berlin, 13353, Germany

Location

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. C. Spies

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 27, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

DE (1)