Sleep QualityWEAN SLEEP 1NCT02920281
Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation
A study testing Polysomnography in people with Sleep Quality and Weaning of Mechanical Ventilation, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Weaning of Mechanical Ventilation
- What is being tested?
- Polysomnography
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation for at least 24 hours before the first weaning test
- difficult weaning of mechanical ventilation defined as failure to the first weaning test
- patients aged at least of 18 years
Who cannot join
- peripheral or central nervous system pathology
- known psychiatric pathology or agitation
- clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale < 8, PaO2/FiO2 ratio < 150 with respiratory distress signs)
- pregnant or breastfeeding women
- patient under legal guardianship or protection
- patient with no health insurance coverage
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients
- Conditions
- Sleep Quality, Weaning of Mechanical Ventilation
- Being tested
- Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920281
- Sponsor's protocol ID
- WEAN SLEEP 1
- Acronym
- WEAN SLEEP 1
- Status last verified
- Jan 2018
- First submitted
- 29 Sep 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
Publications
Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4):1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.
PubMed 29519925
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02920281
- Acronym / sponsor ID
- WEAN SLEEP 1 / WEAN SLEEP 1
- Conditions
- Sleep Quality, Weaning of Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation for at least 24 hours before the first weaning test
- difficult weaning of mechanical ventilation defined as failure to the first weaning test
- patients aged at least of 18 years
Key exclusion criteria (7 listed)
- peripheral or central nervous system pathology
- known psychiatric pathology or agitation
- clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale < 8, PaO2/FiO2 ratio < 150 with respiratory distress signs)
- pregnant or breastfeeding women
- patient under legal guardianship or protection
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 |
|---|---|---|
| Polysomnography | Other | – |
Primary outcome
Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.
Time frame: 24 hours
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 17 Jan 2018.
- Derived from this study: PubMed 29519925Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4):1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with Sleep Quality and Weaning of Mechanical Ventilation, run by Poitiers University Hospital 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 3 inclusion and 7 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 17 Jan 2018. 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?
Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep. (time frame: 24 hours). 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 NCT02920281, which also lists 1 linked publication.
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 17 Jan 2018.