Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I (DIAPASOM)
|ClinicalTrials.gov Identifier: NCT00805974|
Recruitment Status : Terminated (difficulties for including diabetic patients)
First Posted : December 10, 2008
Last Update Posted : January 14, 2009
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.
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes||Biological: Biological examinations (blood and urinary).|
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.
- Biological examinations (blood and urinary).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I|
|Study Start Date :||October 2005|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
- Polysomnographic measurements during the D0-D1 night spend at the hospital [ Time Frame: inclusion visit ]
- Ambulatory blood pressure monitoring on 24 hours [ Time Frame: inclusion visit ]
- Glycemic measurements on 24h (D0-D1). [ Time Frame: inclusion visit ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805974
|Principal Investigator:||MALLION Jean-Michel, Pr||University Hospital, Grenoble|