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NCT Number: NCT03572920

Sleep Behavior and Rest-activity Circadian Rhythm (RAR) in 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.

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Key information

Conditions

Sleep Arthroplasty Complications Hospitalization Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms RAR Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Objective sleep evaluation by actigraphy

Device

Each subject will wear a wrist activity monitor (actigraphy) to detect his/her sleep behaviour during hospitalization.

Pittsburgh Sleep Quality Index (PSQI)

Other

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.

Primary outcomes

  1. Rest-activty Circadian rhythm (RAR) by actigraphy

    Time frame: At baseline untill 10th hospitalization day.

    The 24-hrs daily rhythm of activity levels.

  2. Sleep Efficiency (SE) by actigraphy

    Time frame: At baseline untill 10th hospitalization day.

    The percentage of time in bed spent actually sleeping.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

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

Acronym: Sleep&RAR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2018
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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