NCT03572920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 23, 2021

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

June 19, 2018

Last Update Submit

April 21, 2021

Conditions

SleepPainHospitalizationArthroplasty ComplicationsRAR

Keywords

SleepActigraphyPainPatientsHospitalizationHip ReplacementKnee ReplacementArthroplastyRAR

Outcome Measures

Primary Outcomes (6)

  • Rest-activty Circadian rhythm (RAR) by actigraphy

    The 24-hrs daily rhythm of activity levels.

    At baseline untill 10th hospitalization day.

  • Sleep Efficiency (SE) by actigraphy

    The percentage of time in bed spent actually sleeping.

    At baseline untill 10th hospitalization day.

  • Sleep Latency (SL) by actigraphy

    The period of time required for sleep onset after retiring to bed.

    At baseline untill 10th hospitalization day.

  • 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.

  • 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.

  • 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.

Study Arms (1)

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 actigraphyOther: Pittsburgh Sleep Quality Index (PSQI)

Interventions

Objective sleep evaluation by actigraphyDEVICE

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

Patients with hip/knee arthroplasty.
Pittsburgh Sleep Quality Index (PSQI)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.

Patients with hip/knee arthroplasty.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 patients undergoing total knee or hip replacement surgery.

You may qualify if:

  • Male of female subjects aged between 50 and 80 years old.
  • Knee or Hip Arthroplasty at IRCCS Galeazzi Orthopedic Institute.
  • Cognitively intact
  • Informed signed consent.

You may not qualify if:

  • Cancer history.
  • Body Mass Index \< 18.5 e \> 40.0.
  • Melaton consumption.
  • Previous clinical sleep disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Related Publications (8)

  • 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.

    PMID: 22654183BACKGROUND

  • 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.

    PMID: 17067643BACKGROUND

  • 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.

    PMID: 17765012BACKGROUND

  • 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.

    PMID: 25469597BACKGROUND

  • 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.

    PMID: 22831887BACKGROUND

  • 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.

    PMID: 21388906BACKGROUND

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

    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.

    PMID: 18468312BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catia Pelosi, MD

    IRCCS Galeazzi Orthopedic Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 28, 2018

Study Start

June 19, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 23, 2021

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)