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Nursing Activity and Quality of Hospitalized Patients' Sleep (SOMACTIV)

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: NCT03370354
Recruitment Status : Unknown
Verified December 2017 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
This study is to determine the impact of night shift nurse's activity on patients' sleeping patterns in medical services including individual, clinical and environmental factors. The patients will be questioned in order to create both a control group and a group with troubled sleeping patterns.

Condition or disease Intervention/treatment
Sleep Disorders, Circadian Rhythm Behavioral: Observational

Detailed Description:

There are 5 speciality medical units involved. Patients must respond to the define inclusion criteria. Each patient will be asked if they agree to participate and if so will be asked to consent to participate.

Every day, nurses will give a questionnaire which will be completed by the patient to know if there were troubles sleeping patterns. If so, a second questionnaire will be completed by the patient.

Other data will be recorded such as personal informations, diagnostic, medical history, consumption habits and treatments.

The inclusion phase lasts 15 days maximum.

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Study Type : Observational
Estimated Enrollment : 328 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 15, 2019

Group/Cohort Intervention/treatment
Control group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is > 18, the patient will be in the control group.
troubled sleeping patterns group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is < 18, the patient will be in the troubled patterns group.
Behavioral: Observational
Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.




Primary Outcome Measures :
  1. Presence of a sleeping disorder partially or totally related, according to patient's opinion, to night nursing activity [ Time Frame: At the end of participation of patient- maximum at day 15 after inclusion ]

Secondary Outcome Measures :
  1. Part of patients declaring disturbing elements related to night nursing activity [ Time Frame: At day 15 after inclusion ]
    A follow up sheet is completed every day by a study nurse who asks to patient if the patient sleeps well during the previous night

  2. Disturbing elements related to night nursing activity [ Time Frame: Every day during 15 days ]
    A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him

  3. Individual and clinical disturbing elements [ Time Frame: Every day during 15 days ]
    A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him

  4. Average length of patients' sleep in patients with troubled sleeping during hospitalization [ Time Frame: Every day during 15 days ]
    Estimated with the Vis Morgen self administered questionnaire

  5. Sleep quality measured by Spiegel score [ Time Frame: Every day during 15 days ]
    Score from 0 to 30



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients hospitalized in a speciality medical units and who respond to the defined inclusion criteria. 5 units participate: nephrologye, neurology, cardiology, pneumology, endocrinology.
Criteria

Inclusion Criteria:

  • Patient hospitalize in medical units
  • In the unit since one night
  • Patient over 18 years old
  • Patient agree to participate

Exclusion Criteria:

  • Patient who can't answer to the questionnaire for health reasons
  • Patient who need a specific surveillance
  • Patient recently operated

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): NCT03370354


Contacts
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Contact: Bridey Céline +33383154081 c.bridey@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein
Investigators
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Principal Investigator: Bridey Céline CHRU Nancy France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03370354    
Other Study ID Numbers: 2017-A02076-47
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
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
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases