ARDSCOVISLEEPNCT04371029
Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
A study testing PSG in people with ARDS and COVID-19, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- PSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2020to 9 Dec 2020
- 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
- Patient above 18 year-old admitted to intensive care unit
- COVID-19 assessed by PCR on nasopharyngeal swab or pulmonary sample
- Oro-tracheal intubation for mechanical ventilation
Who cannot join
- Guardianship or curatorship
- Prisoners
- No health insurance
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
Read the detailed description
Sleep alteration is a common problem among ventilated ICU patient. About one third of the patient have abnormal EEG pattern which cannot be scored by using the AASM standard criteria. Patients experience marked fragmentation, absence of deep sleep, and REM sleep is decreased, . It has been shown that sleep deprivation has a negative impact on respiratory muscle endurance. So a good sleep is essential when the respiratory system is being challenged, as in the ICU during the weaning period. Indeed, in the ICU, patients with altered sleep, had a markedly longer weaning duration than in patients with normal sleep, and are more likely to fail a spontaneous breathing trial. Many factors may influence the quality of sleep in the ICU (noise, medication, mechanical ventilation …) but few studies have focus on the cause of this altered sleep, and the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Mechanical ventilation can decrease the charge imposed on the respiratory pump, and allows muscle to rest. Indeed, when the charge is too high (for example after an ARDS during the weaning period), the diaphragm may be overloaded, and there could be a greater involvement of other inspiratory muscles in breathing. In other pathological condition, the neck inspiratory muscle activity is increased (e.g. COPD, amyotrophic lateral sclerosis), and sometimes this activity persist during sleep with marked degradation in sleep architecture. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Ttherefore, the aim of tis study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
- Being tested
- PSG
- Keywords
- Neck inspiratory muscle (=NIM), Sleep, Intensive care unit, ARDS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGOther
Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | A Polysomnography (PSG) will be performed in all patient the night before extubation, the day prior discharge and 3 month after. Recording will consist in EEG, EOG et EMG of the chin. We will record NIM EMG. We will also performed an actimetry during hospitalization in the post ICU ward. A quality of sleep questionnaire (Pittsburgh questionnaire) will be completed by the patients during the visit at 3 month. Receives: Other: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with altered spleep
Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.
Measured: At day 10 after inclusion
Secondary outcomes (5)
Sleep architecture at hospital discharge
Thanks to a PSG the night befor discharge, the seep architecture will be estimated.
Measured: At day 28 after inclusion
Sleep monitoring during hospital stay after ICU discharge
Thanks to actimetry measure during hospitalization in the post ICU ward.
Measured: At day 18 after ICU discharge
Sleep quality
Sleep quality will be evaluate by the Pittsburgh sleep quality index. The 7 components of the score add up for give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Measured: 3 months after hospiotal discharge
Sleep architecture at month-3
Thanks to a PSG at 3 months, the seep architecture will be estimated.
Measured: 3 months after hospital discharge
Cost of ICU hospitalization
all cost will be estimated during ICU hospitalization.
Measured: From inclusion to ICU discharge, up to 10 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start28 Apr 2020
- Primary completion9 Sep 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371029
- Sponsor's protocol ID
- CHUBX 2020/14
- Other IDs
- 2020-A00994-35
- Acronym
- COVISLEEP
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2020
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
- ClinicalTrials.gov ID
- NCT04371029
- Acronym / sponsor ID
- COVISLEEP / CHUBX 2020/14
- Keywords
- Neck inspiratory muscle (=NIM), Sleep, Intensive care unit, ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 1 May 2020 (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.
Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
Detailed description
Sleep alteration is a common problem among ventilated ICU patient. About one third of the patient have abnormal EEG pattern which cannot be scored by using the AASM standard criteria. Patients experience marked fragmentation, absence of deep sleep, and REM sleep is decreased, . It has been shown that sleep deprivation has a negative impact on respiratory muscle endurance. So a good sleep is essential when the respiratory system is being challenged, as in the ICU during the weaning period. Indeed, in the ICU, patients with altered sleep, had a markedly longer weaning duration than in patients with normal sleep, and are more likely to fail a spontaneous breathing trial. Many factors may influence the quality of sleep in the ICU (noise, medication, mechanical ventilation …) but few studies have focus on the cause of this altered sleep, and the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Mechanical ventilation can decrease the charge imposed on the respiratory pump, and allows muscle to rest. Indeed, when the charge is too high (for example after an ARDS during the weaning period), the diaphragm may be overloaded, and there could be a greater involvement of other inspiratory muscles in breathing. In other pathological condition, the neck inspiratory muscle activity is increased (e.g. COPD, amyotrophic lateral sclerosis), and sometimes this activity persist during sleep with marked degradation in sleep architecture. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Ttherefore, the aim of tis study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: PSGA Polysomnography (PSG) will be performed in all patient the night before extubation, the day prior discharge and 3 month after. Recording will consist in EEG, EOG et EMG of the chin. We will record NIM EMG. We will also performed an actimetry during hospitalization in the post ICU ward. A quality of sleep questionnaire (Pittsburgh questionnaire) will be completed by the patients during the visit at 3 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient above 18 year-old admitted to intensive care unit
- COVID-19 assessed by PCR on nasopharyngeal swab or pulmonary sample
- Oro-tracheal intubation for mechanical ventilation
Key exclusion criteria (4 listed)
- Guardianship or curatorship
- Prisoners
- No health insurance
- Pregnancy
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 |
|---|---|---|
| PSGPolysomnography at 3 times, actimetry measure and Pittsburgh questionnaire | Other | Experimental |
Primary outcome
Proportion of patients with altered spleep
Time frame: At day 10 after inclusion
Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.
5 secondary outcomes
Sleep architecture at hospital discharge
Time frame: At day 28 after inclusion
Sleep monitoring during hospital stay after ICU discharge
Time frame: At day 18 after ICU discharge
Sleep quality
Time frame: 3 months after hospiotal discharge
Sleep architecture at month-3
Time frame: 3 months after hospital discharge
Cost of ICU hospitalization
Time frame: From inclusion to ICU discharge, up to 10 days after inclusion
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 22 May 2026.
- 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.
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 PSG in people with ARDS and COVID-19, run by University Hospital, Bordeaux 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 4 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 22 May 2026. 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?
Proportion of patients with altered spleep (time frame: At day 10 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 22 May 2026.