Clinical trial NCT03572920: Sleep Behavior and Rest-activity Circadian Rhythm (RAR) in Hip/Knee Prosthesis
Official title: Actigraphy-based RAR and Sleep Behavior in Hospitalized Patients for Hip/Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Pain
Hospitalization
Arthroplasty Complications
RAR
Keywords: Sleep
Actigraphy
Pain
Patients
Hospitalization
Hip Replacement
Knee Replacement
Arthroplasty
RAR
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients undergoing total knee or hip replacement surgery.

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.

Eligibility 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.

Primary outcomes:
measure: Rest-activty Circadian rhythm (RAR) by actigraphy
timeFrame: At baseline untill 10th hospitalization day.
measure: Sleep Efficiency (SE) by actigraphy
timeFrame: At baseline untill 10th hospitalization day.
measure: Sleep Latency (SL) by actigraphy
timeFrame: At baseline untill 10th hospitalization day.
measure: Assumed Sleep (AS) by actigraphy
timeFrame: At baseline untill 10th hospitalization day.
measure: Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: At baseline and at the 10th hospitalization day.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Every day, from baseline untill the 10th hospitalization day.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Galeazzi Orthopedic Institute
name: Catia Pelosi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Atkinson G, Davenne D. Relationships between sleep, physical activity and human health. Physiol Behav. 2007 Feb 28;90(2-3):229-35. doi: 10.1016/j.physbeh.2006.09.015. Epub 2006 Oct 25.
citation: 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. doi: 10.1016/j.sleep.2007.06.009. Epub 2007 Aug 30.
citation: 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.
citation: 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.
citation: 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.
citation: 7. Morin CM, Espie CA. Insomnia: A Clinical Guide to Assessment and Treatment. New York: Springer Science, 2004.
citation: 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.