Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I (DIAPASOM)
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|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||Phase|
|Type 1 Diabetes||Biological: Biological examinations (blood and urinary).||Not Applicable|
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|
|Actual Primary Completion Date :||December 2007|
|Actual 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 ]
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): NCT00805974
|Principal Investigator:||MALLION Jean-Michel, Pr||University Hospital, Grenoble|