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Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS

Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04371029
Acronym
COVISLEEP
Enrollment
17
Registered
2020-05-01
Start date
2020-04-28
Completion date
2020-12-09
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, COVID-19

Keywords

Neck inspiratory muscle (=NIM), Sleep, Intensive care unit, ARDS

Brief 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. 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).

Interventions

OTHERPSG

Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Guardianship or curatorship * Prisoners * No health insurance * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with altered spleepAt day 10 after inclusionComparison 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.

Secondary

MeasureTime frameDescription
Sleep architecture at hospital dischargeAt day 28 after inclusionThanks to a PSG the night befor discharge, the seep architecture will be estimated.
Sleep monitoring during hospital stay after ICU dischargeAt day 18 after ICU dischargeThanks to actimetry measure during hospitalization in the post ICU ward.
Sleep quality3 months after hospiotal dischargeSleep 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.
Sleep architecture at month-33 months after hospital dischargeThanks to a PSG at 3 months, the seep architecture will be estimated.
Cost of ICU hospitalizationFrom inclusion to ICU discharge, up to 10 days after inclusionall cost will be estimated during ICU hospitalization.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026