Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I — DIAPASOM  

Type 1 Diabetes Clinical Trial

Official title: Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

Status Terminated

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Type 1 Diabetes

• NCT number: NCT00805974
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Terminated
• Phase: N/A
• Start date: October 2005
• Completion date: December 2007