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SleepSleep&RARNCT03572920

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

An observational study of Sleep and Pain, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Sleep, Pain, Hospitalization
What is being tested?
Objective sleep evaluation by actigraphy and Pittsburgh Sleep Quality Index (PSQI)
Type of treatment
Medical device
How many people
20 participants
Where
1 siteItaly
Study dates
19 Jun 2018to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 20 patients undergoing total knee or hip replacement surgery.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Istituto Ortopedico Galeazzi

    Milan, 20161

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Objective sleep evaluation by actigraphy, Pittsburgh Sleep Quality Index (PSQI)
Keywords
Sleep, Actigraphy, Pain, Patients, Hospitalization, Hip Replacement, Knee Replacement, Arthroplasty, RAR
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Objective sleep evaluation by actigraphyDevice

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

  • 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.

Study groups in NCT03572920
Study groupRoleWhat they receive
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).
Receives: Device: Objective sleep evaluation by actigraphy; Other: Pittsburgh Sleep Quality Index (PSQI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rest-activty Circadian rhythm (RAR) by actigraphy

    The 24-hrs daily rhythm of activity levels.

    Measured: At baseline untill 10th hospitalization day.

  2. Sleep Efficiency (SE) by actigraphy

    The percentage of time in bed spent actually sleeping.

    Measured: At baseline untill 10th hospitalization day.

  3. Sleep Latency (SL) by actigraphy

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

    Measured: At baseline untill 10th hospitalization day.

  4. Assumed Sleep (AS) by actigraphy

    The difference in hours and minutes between the Sleep end and Sleep start times.

    Measured: At baseline untill 10th hospitalization day.

  5. 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.

    Measured: At baseline and at the 10th hospitalization day.

  6. 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.

    Measured: Every day, from baseline untill the 10th hospitalization day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start19 Jun 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03572920
Sponsor's protocol ID
Sonno&protesi
Acronym
Sleep&RAR
Status last verified
Jul 2018
First submitted
19 Jun 2018
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22654183

  • 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.

    PubMed 17067643

  • 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.

    PubMed 17765012

  • 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.

    PubMed 25469597

  • 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.

    PubMed 22831887

  • 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.

    PubMed 21388906

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

  • 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.

    PubMed 18468312

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep and Pain, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rest-activty Circadian rhythm (RAR) by actigraphy (time frame: At baseline untill 10th hospitalization day.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03572920, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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