Sleep Disorders, Circadian RhythmSOMACTIVNCT03370354
Nursing Activity and Quality of Hospitalized Patients' Sleep
An observational study of Sleep Disorders, Circadian Rhythm, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm
- What is being tested?
- Observational
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 15 Aug 2019
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patient hospitalize in medical units
- In the unit since one night
- Patient over 18 years old
- Patient agree to participate
Who cannot join
- Patient who can't answer to the questionnaire for health reasons
- Patient who need a specific surveillance
- Patient recently operated
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep
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.
Read the 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.
- Conditions
- Sleep Disorders, Circadian Rhythm
- Being tested
- Observational
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalBehavioural
Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a sleeping disorder partially or totally related, according to patient's opinion, to night nursing activity
Measured: 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
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
Measured: At day 15 after inclusion
Disturbing elements related to night nursing activity
A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him
Measured: Every day during 15 days
Individual and clinical disturbing elements
A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him
Measured: Every day during 15 days
Average length of patients' sleep in patients with troubled sleeping during hospitalization
Estimated with the Vis Morgen self administered questionnaire
Measured: Every day during 15 days
Sleep quality measured by Spiegel score
Score from 0 to 30
Measured: Every day during 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion15 Aug 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein
- Responsible party
- Sponsor
- Investigators
- Bridey Céline, Principal investigator, CHRU Nancy France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370354
- Sponsor's protocol ID
- 2017-A02076-47
- Acronym
- SOMACTIV
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep
- ClinicalTrials.gov ID
- NCT03370354
- Acronym / sponsor ID
- SOMACTIV / 2017-A02076-47
- Conditions
- Sleep Disorders, Circadian Rhythm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: ObservationalFirst questionnaire (spiegel questionnaire) will allow a score on 30. If the score is < 18, the patient will be in the troubled patterns group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patient hospitalize in medical units
- In the unit since one night
- Patient over 18 years old
- Patient agree to participate
Key exclusion criteria (3 listed)
- Patient who can't answer to the questionnaire for health reasons
- Patient who need a specific surveillance
- Patient recently operated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAsk patients about sleep quality and identify reasons of troubled sleeping patterns in the units. | Behavioural | troubled sleeping patterns group |
Primary outcome
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
5 secondary outcomes
Part of patients declaring disturbing elements related to night nursing activity
Time frame: At day 15 after inclusion
Disturbing elements related to night nursing activity
Time frame: Every day during 15 days
Individual and clinical disturbing elements
Time frame: Every day during 15 days
Average length of patients' sleep in patients with troubled sleeping during hospitalization
Time frame: Every day during 15 days
Sleep quality measured by Spiegel score
Time frame: Every day during 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridey Céline principal investigator
CHRU Nancy France
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, Circadian Rhythm, run by Central Hospital, Nancy, France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bridey Céline (+33383154081, c.bridey@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2017.