NCT03370354

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Status
unknown

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

November 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1.5 years

First QC Date

November 30, 2017

Last Update Submit

December 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of a sleeping disorder partially or totally related, according to patient's opinion, to night nursing activity

    At the end of participation of patient- maximum at day 15 after inclusion

Secondary Outcomes (5)

  • Part of patients declaring disturbing elements related to night nursing activity

    At day 15 after inclusion

  • Disturbing elements related to night nursing activity

    Every day during 15 days

  • Individual and clinical disturbing elements

    Every day during 15 days

  • Average length of patients' sleep in patients with troubled sleeping during hospitalization

    Every day during 15 days

  • Sleep quality measured by Spiegel score

    Every day during 15 days

Study Arms (2)

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

Interventions

ObservationalBEHAVIORAL

Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.

troubled sleeping patterns group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Bridey Céline

    CHRU Nancy France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 12, 2017

Study Start

February 1, 2018

Primary Completion

August 15, 2019

Study Completion

August 15, 2019

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share