Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00805974
Status:
TERMINATED
Last Update Posted:
2009-01-14
First Post:
2008-12-09
Brief Title:
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulties for including diabetic patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAPASOM
Brief Summary:
The primary objectives are to compare the mean levels of the sleep quality parameters of subjects with a nocturnal fall of the SBP Systolic blood pressure DBP diastolic blood pressure and MAP mean arterial pressure over of egal to 10 dipping subjects and of subjects with a nocturnal fall of SBP DBP and MAP inferior to 10 non dipper subjects
The secondary objectives are
Establish correlations between
The quality of sleep parameters
The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography
The glycemia levels on 24h with a glycemic holter The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period
The secondary objectives are
Establish correlations between
The quality of sleep parameters
The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography
The glycemia levels on 24h with a glycemic holter The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period
Detailed Description:
It is a prospective monocentric study after a preliminary period of depistage of the sleep abnormalities by oximetry at home The patient would be hospitalized for two consecutive days J0 J1 And the following evaluations will be done
Nocturnal oxymetric Epworth questionnaire clinical questionnaire to detect sleep perturbations at home
Blood pressure heart rate measure
Ambulatory blood pressure monitoring on 24 hours
Polysomnographic measurements during the J0-J1 night spend at the hospital
Questionnaire of sleep quality and of quality of life
Glycemic measurements on 24h J0-J1
Measure of the baroreflex sensibility during the awake period at J1
Electrocardiogram
Biological examinations blood and urinary
Nocturnal oxymetric Epworth questionnaire clinical questionnaire to detect sleep perturbations at home
Blood pressure heart rate measure
Ambulatory blood pressure monitoring on 24 hours
Polysomnographic measurements during the J0-J1 night spend at the hospital
Questionnaire of sleep quality and of quality of life
Glycemic measurements on 24h J0-J1
Measure of the baroreflex sensibility during the awake period at J1
Electrocardiogram
Biological examinations blood and urinary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20050479 | None | None | None |