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

Pain Clinical Trial

— Sleep&RAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572920
• Other study ID #: Sonno&protesi
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2018
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hospitalization
• Pain
• Sleep

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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

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. — View 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. Epub 2007 Aug 30. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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