Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS (COVISLEEP)
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|ClinicalTrials.gov Identifier: NCT04371029|
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|ARDS COVID-19||Other: PSG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS|
|Actual Study Start Date :||April 28, 2020|
|Estimated Primary Completion Date :||September 28, 2020|
|Estimated Study Completion Date :||December 28, 2020|
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.
Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire
- 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.
- Sleep architecture at hospital discharge [ Time Frame: At day 28 after inclusion ]Thanks to a PSG the night befor discharge, the seep architecture will be estimated.
- Sleep monitoring during hospital stay after ICU discharge [ Time Frame: At day 18 after ICU discharge ]Thanks to actimetry measure during hospitalization in the post ICU ward.
- Sleep quality [ Time Frame: 3 months after hospiotal discharge ]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.
- Sleep architecture at month-3 [ Time Frame: 3 months after hospital discharge ]Thanks to a PSG at 3 months, the seep architecture will be estimated.
- Cost of ICU hospitalization [ Time Frame: From inclusion to ICU discharge, up to 10 days after inclusion ]all cost will be estimated during ICU hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371029
|Contact: Renaud PREVEL, Dr||5 56 79 55 17 ext +email@example.com|
|Contact: Léo GRASSION, Dr||5 57 65 63 38 ext +firstname.lastname@example.org|