Sleep QualityHIGH SLEEPNCT02907008
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure
An observational study of Sleep Quality and Hypoxemic Acute Respiratory Failure, 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 intubation rate in intensive care units patients with acute respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Hypoxemic Acute Respiratory Failure, Intubation Risk
- What is being tested?
- Polysomnography
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care units patients with hypoxemic acute respiratory failure
Who may be able to join
- Acute respiratory failure
- hypoxemia with PaO2/FiO2 ratio < 300 mmHg
- aged of 18 years or more
Who cannot join
- Need of immediate intubation
- Need of vasopressor drugs
- coma with Glasgow scale < 8
- Acute respiratory failure linked to cardiogenic pulmonary oedema
- Chronic respiratory insufficiency
- Peripheral or central nervous system pathology
Show all 12Show fewer
- Known psychiatric pathology or agitation
- Patient with decision of no intubation
- Patient refusal
- Pregnant or breastfeeding women
- Patient under legal guardianship or protection
- Patients with no health insurance coverage
Trial locations and contacts
1 site in 1 country.
Arnaud W THILLE, PHD contact
Damien MARIE, Intern contact
France1 site, 1 recruiting
- Recruiting
Chu Poitiers
Poitiers, 86000
Arnaud W THILLE, PHD, arnaud.thille@chu-poitiers.fr
About this study
The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure
- Being tested
- Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Respiratory Insufficiency
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.
to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 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
- NCT02907008
- Sponsor's protocol ID
- HIGH SLEEP
- Acronym
- HIGH SLEEP
- Status last verified
- Feb 2019
- First submitted
- 15 Sep 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT02907008
- Acronym / sponsor ID
- HIGH SLEEP / HIGH SLEEP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 20 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 intubation rate in intensive care units patients with acute respiratory failure
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care units patients with hypoxemic acute respiratory failure
Key inclusion criteria (3 listed)
- Acute respiratory failure
- hypoxemia with PaO2/FiO2 ratio < 300 mmHg
- aged of 18 years or more
Key exclusion criteria (12 listed)
- Need of immediate intubation
- Need of vasopressor drugs
- coma with Glasgow scale < 8
- Acute respiratory failure linked to cardiogenic pulmonary oedema
- Chronic respiratory insufficiency
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
to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep
Time frame: 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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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.
Arnaud W THILLE, PHD contact
Damien MARIE, Intern contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Quality and Hypoxemic Acute Respiratory Failure, 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 12 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 22 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud W THILLE, PHD (arnaud.thille@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep (time frame: 24h). 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 22 Feb 2019.