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

April 21, 2021 updated by: Istituto Ortopedico Galeazzi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 patients undergoing total knee or hip replacement surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with hip/knee arthroplasty.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rest-activty Circadian rhythm (RAR) by actigraphy
Time Frame: At baseline untill 10th hospitalization day.
The 24-hrs daily rhythm of activity levels.
At baseline untill 10th hospitalization day.
Sleep Efficiency (SE) by actigraphy
Time Frame: At baseline untill 10th hospitalization day.
The percentage of time in bed spent actually sleeping.
At baseline untill 10th hospitalization day.
Sleep Latency (SL) by actigraphy
Time Frame: At baseline untill 10th hospitalization day.
The period of time required for sleep onset after retiring to bed.
At baseline untill 10th hospitalization day.
Assumed Sleep (AS) by actigraphy
Time Frame: At baseline untill 10th hospitalization day.
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
Time Frame: 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.
At baseline and at the 10th hospitalization day.
Epworth Sleepiness Scale (ESS)
Time Frame: 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.
Every day, from baseline untill the 10th hospitalization day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Study Director: Catia Pelosi, MD, IRCCS Galeazzi Orthopedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sonno&protesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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