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

• ClinicalTrials.gov Identifier: NCT03572920
• Recruitment Status: Completed
• First Posted: June 28, 2018
• Last Update Posted: April 23, 2021
• Sponsor: Istituto Ortopedico Galeazzi
• Information provided by (Responsible Party): Istituto Ortopedico Galeazzi

Study Description

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.

Condition or disease	Intervention/treatment
Sleep; Pain; Hospitalization; Arthroplasty Complications; RAR	Device: Objective sleep evaluation by actigraphy; Other: Pittsburgh Sleep Quality Index (PSQI)

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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Actigraphy-based RAR and Sleep Behavior in Hospitalized Patients for Hip/Knee Prosthesis
• Actual Study Start Date: June 19, 2018
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

20 patients undergoing total knee or hip replacement surgery.

Criteria

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.

Contacts and Locations

Locations

Italy

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy, 20161

Sponsors and Collaborators

Istituto Ortopedico Galeazzi

Investigators

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

More Information

Publications:

Luyster FS, Strollo PJ Jr, Zee PC, Walsh JK; Boards of Directors of the American Academy of Sleep Medicine and the Sleep Research Society. Sleep: a health imperative. Sleep. 2012 Jun 1;35(6):727-34. doi: 10.5665/sleep.1846.

Atkinson G, Davenne D. Relationships between sleep, physical activity and human health. Physiol Behav. 2007 Feb 28;90(2-3):229-35. Epub 2006 Oct 25. Review.

de Castro Toledo Guimaraes LH, de Carvalho LB, Yanaguibashi G, do Prado GF. Physically active elderly women sleep more and better than sedentary women. Sleep Med. 2008 Jul;9(5):488-93. Epub 2007 Aug 30.

Vitale JA, Roveda E, Montaruli A, Galasso L, Weydahl A, Caumo A, Carandente F. Chronotype influences activity circadian rhythm and sleep: differences in sleep quality between weekdays and weekend. Chronobiol Int. 2015 Apr;32(3):405-15. doi: 10.3109/07420528.2014.986273. Epub 2014 Dec 3.

Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.

Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.

7. Morin CM, Espie CA. Insomnia: A Clinical Guide to Assessment and Treatment. New York: Springer Science, 2004.

Jacobson SA, Dwyer PC, Machan JT, Carskadon MA. Quantitative analysis of rest-activity patterns in elderly postoperative patients with delirium: support for a theory of pathologic wakefulness. J Clin Sleep Med. 2008 Apr 15;4(2):137-42.

• Responsible Party: Istituto Ortopedico Galeazzi
• ClinicalTrials.gov Identifier: NCT03572920
• Other Study ID Numbers: Sonno&protesi
• First Posted: June 28, 2018
• Last Update Posted: April 23, 2021
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Ortopedico Galeazzi:

Sleep; Actigraphy; Pain; Patients; Hospitalization; Hip Replacement; Knee Replacement; Arthroplasty; RAR