NapMARIENAIENCT05378789
Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review
A study testing Nap in people with Nap, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nap
- What is being tested?
- Nap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2022to 31 Aug 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center.
Who cannot join
- Pregnant woman.
- Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project.
- Caregiver refusing to participate in the project.
Trial locations and contacts
1 site in 1 country.
About this study
MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.
This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).
- Conditions
- Nap
- Being tested
- Nap
- Keywords
- nap; ICU; nurse; Shift work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapProcedure or surgery
ICU nurses can take a 20-mn nap between 2 and 5 am according to a rotation of personal.
Naps will be carried out with the help of a Nap and Up ® cocoon deckchair.
| Study group | Role | What they receive |
|---|---|---|
| 20-min nap | Experimental | ICU nurses can take a 20-minute nap between 2 and 5 am according to a rotation of personal.
Naps will be carried out with the help of a Nap and Up ® cocoon deckchair. Receives: Procedure: Nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nap appropriation
Proportion of the number of nights worked with micro-naps to the number of nights worked by a caregiver over a year.
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start30 May 2022
- Primary completion15 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NapStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélanie ROUGIER, Principal investigator, Centre hospitalier departemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378789
- Sponsor's protocol ID
- CHD21_0119
- Acronym
- MARIENAIE
- Status last verified
- Dec 2023
- First submitted
- 13 May 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review
- ClinicalTrials.gov ID
- NCT05378789
- Acronym / sponsor ID
- MARIENAIE / CHD21_0119
- Conditions
- Nap
- Keywords
- nap; ICU; nurse; Shift work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 May 2022 (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.
MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.
This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20-min nap | Experimental | Procedure: NapICU nurses can take a 20-minute nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center.
Key exclusion criteria (3 listed)
- Pregnant woman.
- Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project.
- Caregiver refusing to participate in the project.
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 |
|---|---|---|
| NapICU nurses can take a 20-mn nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair. | Procedure or surgery | 20-min nap |
Primary outcome
Nap appropriation
Time frame: 12 months after baseline
Proportion of the number of nights worked with micro-naps to the number of nights worked by a caregiver over a year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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.
Mélanie ROUGIER principal investigator
Centre hospitalier departemental Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap in people with Nap, run by Centre Hospitalier Departemental Vendee at 1 site in 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 1 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: finished, as of the sponsor's last update on 12 Dec 2023. 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 France. 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?
Nap appropriation (time frame: 12 months after baseline). 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 2023; AzTrials last refreshed its copy on 8 Nov 2026.