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

NCT ID: NCT03572920

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2020-06-30

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.

Conditions

Sleep; Pain; Hospitalization; Arthroplasty Complications; RAR

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Objective sleep evaluation by actigraphy

Intervention Type: DEVICE

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

Pittsburgh Sleep Quality Index (PSQI)

Intervention Type: 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.

Interventions

Objective sleep evaluation by actigraphy

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catia Pelosi, MD

Role: STUDY_DIRECTOR

IRCCS Galeazzi Orthopedic Institute

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Countries

Italy

References

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Reference Type: BACKGROUND

PMID: 22654183 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17067643 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17765012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25469597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22831887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21388906 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18468312 (View on PubMed)

Other Identifiers

Sonno&protesi

Identifier Type: -

Identifier Source: org_study_id