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Sleep Behavior and Hip/Knee Prosthesis (Sleep)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572920
Recruitment Status : Unknown
Verified July 2018 by Istituto Ortopedico Galeazzi.
Recruitment status was:  Recruiting
First Posted : June 28, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

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 in 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 Device: Objective sleep evaluation by actigraphy Other: Pittsburgh Sleep Quality Index (PSQI) Other: Epworth Sleepiness Scale (ESS)

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Actigraphy-based Sleep Behavior in Hospitalized Patients for Hip/Knee Prosthesis
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Patients with hip/knee arthroplasty.
Objective sleep evaluation by actigraphy. Pittsburgh Sleep Quality Index (PSQI). Epworth Sleepiness Scale (ESS).
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.

Other: Epworth Sleepiness Scale (ESS)
Each subject will fill the Epworth Sleepiness Scale (ESS) every day, untill the 10th hospitalization day, to evaluate his/her daytime sleepiness.




Primary Outcome Measures :
  1. Sleep Efficiency (SE) by actigraphy [ Time Frame: At baseline untill 10th hospitalization day. ]
    The percentage of time in bed spent actually sleeping.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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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
35 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572920


Contacts
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Contact: Jacopo A Vitale, PhD 0039 0266214881 jacopo.vitale@grupposandonato.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milan, Italy, 20161
Contact: Francesco Negrini, MD    +390266214057    francesco.negrini2@grupposandonato.it   
Principal Investigator: Francesco Negrini, MD         
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Study Director: Catia Pelosi, MD IRCCS Galeazzi Orthopedic Institute
Publications:
7. Morin CM, Espie CA. Insomnia: A Clinical Guide to Assessment and Treatment. New York: Springer Science, 2004.

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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03572920    
Other Study ID Numbers: Sonno&protesi
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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