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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep, Pain, Hospitalization, Arthroplasty Complications, RAR

Intervention / Treatment
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* Device: Objective sleep evaluation by actigraphy
* Other: Pittsburgh Sleep Quality Index (PSQI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male of female subjects aged between 50 and 80 years old. Knee or Hip Arthroplasty at IRCCS Galeazzi Orthopedic Institute. Cognitively intact Inclusion in the rehabilitation program within the Orthopedic Specialist Rehabilitation Unit of IRCCS Galeazzi Orthopedic Institute. Informed signed consent. Exclusion Criteria: Cancer history. Body Mass Index < 18.5 e > 40.0. Melaton consumption. Previous clinical sleep disorders.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hip/knee arthroplasty.<br>RAR description by actgraphy Objective sleep evaluation by actigraphy. Subjective sleep quality with sleep diary Pittsburgh Sleep Quality Index (PSQI). | Device: Objective sleep evaluation by actigraphy<br>* Each subject will wear a wrist activity monitor (actigraphy) to detect his/her sleep behaviour during hospitalization.<br>Other: Pittsburgh Sleep Quality Index (PSQI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rest-activty Circadian rhythm (RAR) by actigraphy | The 24-hrs daily rhythm of activity levels. | At baseline untill 10th hospitalization day. | 
| Sleep Efficiency (SE) by actigraphy | The percentage of time in bed spent actually sleeping. | At baseline untill 10th hospitalization day. | 
| Sleep Latency (SL) by actigraphy | The period of time required for sleep onset after retiring to bed. | At baseline untill 10th hospitalization day. | 
| Assumed Sleep (AS) by actigraphy | The difference in hours and minutes between the Sleep end and Sleep start times. | At baseline untill 10th hospitalization day. | 
| Pittsburgh Sleep Quality Index (PSQI) questionnaire | Evaluation of habitual sleep quality trough a validated questionnaire. 19 items where each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | At baseline and at the 10th hospitalization day. | 
| Epworth Sleepiness Scale (ESS) | Evaluation of daytime sleepiness. 7 item and each item is weighted on a 0-3 interval scale. Range scores from 0 to 21. Higher scores correspond to higher sleepiness status during the day. | Every day, from baseline untill the 10th hospitalization day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Actigraphy, Pain, Patients, Hospitalization, Hip Replacement, Knee Replacement, Arthroplasty, RAR