NCT03572920

Sleep Behavior and Rest-activity Circadian Rhythm (RAR) in Hip/Knee Prosthesis

Actigraphy-based RAR and Sleep Behavior in Hospitalized Patients for Hip/Knee Prosthesis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The consequences of chronically insufficient sleep are both behavioral and medical. . Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization The aim of the present study is to evaluate the changes inrest-activity circadian rhythm (RAR) and objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

Detailed description

The National Health and Nutrition Examination Survey found that 22% of the US population reported 6 h of sleep or less and another 15% registered 5 h of sleep or less per 24 h (1). The consequences of chronically insufficient sleep are both behavioral and medical. Quantity and quality of sleep represent important factors for the quality of life, which can have positive or negative influence on individual health (2-4). Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization (5,6) Such patients experience acute postsurgical pain and discomfort, including restriction of their leg movement to prevent dislocation of the hip implant in the acute stage. The results of previous post-surgery studies have shown that REM sleep was severely reduced and awake time increased on the first postoperative night compared with the preoperative night (7,8).It is necessary for patients to secure the appropriate amount and quality of sleep to facilitate recuperation after surgery. Sleep disturbance is also related to the presence of delirium. The aim of the present study is to evaluate the changes in objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

Conditions

• Sleep
• Pain
• Hospitalization
• Arthroplasty Complications
• RAR

Interventions

Type	Name	Description
DEVICE	Objective sleep evaluation by actigraphy	Each subject will wear a wrist activity monitor (actigraphy) to detect his/her sleep behaviour during hospitalization.
OTHER	Pittsburgh Sleep Quality Index (PSQI)	Each subject will fill twice the Pittsburgh Sleep Quality Index (PSQI), before hospitalization and after the 10th day, to evaluate his/her subjective sleep quality.

Timeline

• Start date: 2018-06-19
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-06-28
• Last updated: 2021-04-23

Locations

1 site across 1 country: Italy