Sleep Apnea SyndromesFOLLOW_EXESASNCT02920723
Follow-up of the Patients Included in the EXESAS Study
A study testing Training in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructives, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructives
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 21 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included in the previous EXESAS study
- Signature of consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of the Patients Included in the EXESAS Study : Analysis of the Profit of the Physical Activity for the Control Group and of the Preservation of a Regular Physical Activity for the Group Initially Trained
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.
Read the detailed description
In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.
This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructives
- Being tested
- Training, Control
- Keywords
- Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called NeuroGyV program
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Measured: 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
Measured: 12 months
Maximal aerobic capacity (VO2Max)
Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Measured: 12 months
Population Physical Activity questionnaire (POPAQ)
Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Measured: 12 months
Daily physical activity energy expenditure
Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Measured: 12 months
Epworth sleepiness Scale
Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups
Measured: 12 months
Pittsburgh questionnaire
Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups
Measured: 12 months
Berlin questionnaire
Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups
Measured: 12 months
Changes in blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD - PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920723
- Sponsor's protocol ID
- 1608082
- Other IDs
- 2016-A00859-42
- Acronym
- FOLLOW_EXESAS
- Status last verified
- Nov 2018
- First submitted
- 29 Sep 2016
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Patients Included in the EXESAS Study : Analysis of the Profit of the Physical Activity for the Control Group and of the Preservation of a Regular Physical Activity for the Group Initially Trained
- ClinicalTrials.gov ID
- NCT02920723
- Acronym / sponsor ID
- FOLLOW_EXESAS / 1608082
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructives
- Keywords
- Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.
This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: TrainingFor 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. |
| Control | Other | Other: ControlFor 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Included in the previous EXESAS study
- Signature of consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingAlso: NeuroGyV program | Other | Training |
| Control | Other | Control |
Primary outcome
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Time frame: 12 months
Apnea-Hypopnea Index (AHI)
10 secondary outcomes
Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Time frame: 12 months
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Time frame: 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
Time frame: 12 months
Maximal aerobic capacity (VO2Max)
Time frame: 12 months
Population Physical Activity questionnaire (POPAQ)
Time frame: 12 months
Daily physical activity energy expenditure
Time frame: 12 months
Epworth sleepiness Scale
Time frame: 12 months
Pittsburgh questionnaire
Time frame: 12 months
Berlin questionnaire
Time frame: 12 months
Changes in blood pressure - Baroreflex
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Website of the FFEPGV (in french)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea Syndromes
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic ROCHE, MD - PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructives, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.