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

Completed

• Conditions: Pain; RAR; Arthroplasty Complications; Sleep; Hospitalization
• Interventions: Device: Objective sleep evaluation by actigraphy; Other: Pittsburgh Sleep Quality Index (PSQI)

• Registration Number: NCT03572920
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief 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.

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-28
• Status Verified: 2018-07
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hip/knee arthroplasty.	Pittsburgh Sleep Quality Index (PSQI)	RAR description by actgraphy Objective sleep evaluation by actigraphy. Subjective sleep quality with sleep diary Pittsburgh Sleep Quality Index (PSQI).
Patients with hip/knee arthroplasty.	Objective sleep evaluation by actigraphy	RAR description by actgraphy Objective sleep evaluation by actigraphy. Subjective sleep quality with sleep diary Pittsburgh Sleep Quality Index (PSQI).

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency (SE) by actigraphy	At baseline untill 10th hospitalization day.	The percentage of time in bed spent actually sleeping.
Pittsburgh Sleep Quality Index (PSQI) questionnaire	At baseline and at the 10th hospitalization day.	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.
Sleep Latency (SL) by actigraphy	At baseline untill 10th hospitalization day.	The period of time required for sleep onset after retiring to bed.
Assumed Sleep (AS) by actigraphy	At baseline untill 10th hospitalization day.	The difference in hours and minutes between the Sleep end and Sleep start times.
Epworth Sleepiness Scale (ESS)	Every day, from baseline untill the 10th hospitalization day.	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.
Rest-activty Circadian rhythm (RAR) by actigraphy	At baseline untill 10th hospitalization day.	The 24-hrs daily rhythm of activity levels.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy