Follow-up of the Patients Included in the EXESAS Study

NCT02920723 | Completed

• 2 other identifiers: 16080822016-A00859-42
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructives

Keywords

Sleep Apnea Syndromes; Sleep Apnea, Obstructives; Training

Outcome Measures

Primary Outcomes (1)

• the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups

  Apnea-Hypopnea Index (AHI)

  12 months

Secondary Outcomes (10)

• Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.

  12 months

• Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.

  12 months

• Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups

  12 months

• Maximal aerobic capacity (VO2Max)

  12 months

• Population Physical Activity questionnaire (POPAQ)

  12 months

Study Arms (2)

Training

EXPERIMENTAL

For the patients who were allocated in the control group in the EXESAS study. In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.

Other: Training

Control

OTHER

For the patients who were allocated in the training group in the EXESAS study. In this group, patients will receive only diets and physical activity counselling

Other: Control

Interventions

Training OTHER

Also known as: NeuroGyV program

Training

Control OTHER

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included in the previous EXESAS study
• Signature of consent

You may not qualify if:

• Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
• Daytime sleepiness (ESS score \> 10)
• Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
• Patients with Parkinson's disease
• AHI \> 30

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Related Links

• Website of the FFEPGV (in french)

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Frederic ROCHE, MD - PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)