Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— OSAS  

Official title:

Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03075787
• Other study ID #: 1700176
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 6, 2017
• Last updated: July 4, 2017
• Start date: September 1, 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Restless legs syndrome patients

• Hospital routine for sleep disorders breathing diagnosis

• Apnea index > 0

Exclusion Criteria:

• Narcolepsy-cataplexy

• Sleep irregularities and sleep deprivation symptoms

• Lack of neurological or psychiatric diseases

• Periodic leg movements

• Central sleep apnea, treatment

• Cerebral lesion

• Medical illness

• Medication or drinks affecting sleep and wake state.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• standard 24-h ambulatory polysomnography
A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of heart rate response associated with obstructive sleep apneas	standard 24-h ambulatory ad libitum polysomnography	At diagnosis
Secondary	Other Heart rate variability indices: Ptot	standard 24-h ambulatory ad libitum polysomnography	At diagnosis
Secondary	Other Heart rate variability indices: very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu)	standard 24-h ambulatory ad libitum polysomnography	At diagnosis
Secondary	Other Heart rate variability indices: LF/HF	standard 24-h ambulatory ad libitum polysomnography	At diagnosis