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Sleep Apnea, ObstructivePhase 3RehsolvasNCT01362777

Rehabilitation Program as an Alternative Therapy for Moderate to Severe Obstructive Sleep Apnea Syndrome

A Phase 3 study testing In-patient rehabilitation and Educational activities alone in people with Sleep Apnea, Obstructive and Metabolic Syndrome, run by 5 Santé at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Sleep Apnea, Obstructive, Metabolic Syndrome
What is being tested?
In-patient rehabilitation and Educational activities alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteFrance
Study dates
Nov 2007to Aug 2010
Phase
Phase 3
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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI > 15/h)
  • Sedentary patient (Activity Voorrips Questionnary score < 9,4)

Who cannot join

  • OSAS already treated by CPAP or other therapy (OAM,...)
  • BMI > 40/m²
  • Hypnotic and sedative medications
  • Cranio-facial malformation
  • Obstructive respiratory disease (COPD, asthma,...)
  • Instable heart ischemic disease and all

Trial locations and contacts

1 site in 1 country.

France1 site
  • Clinique du souffle "La Solane"

    Osséja, 66340

Other trials in France

About this study

Official title: Effects of an In-Patient Individualized Rehabilitation Program on Severity and Symptoms of Obstructive Sleep Apnea Syndrome (OSAS):Results of a Randomized Controlled Pilot Study

The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of traffic accidents but also other cognitive disorders with significant impact on quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and other systemic metabolic dysregulation of many whose levels are correlated with the severity of the disease.

Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept and/or poorly tolerated, limiting its effectiveness.

Read more

Weight loss and regular physical activity are clearly recommended but rarely done in clinical practice. A few studies have applied to study the effects of rehabilitation training (REE) on the sleep apnea patients and have shown an improvement in sleep quality, reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their methodology was questionable, and the number of patients included was too low.

The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program comprising educational activities, dietary management and individualized exercise training (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL). This IET program (24 sessions during 4 weeks) could also help to improve many metabolic dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk). Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may play a role in enabling a better control of ventilation in these patients.

Read the detailed description

The obstructive sleep apnea/hypopnea syndrome (OSAS), with an estimated prevalence of between 2 and 4% (1) is characterized by repetitive obstructions of the upper airway that generate intermittent hypoxemia and sleep fragmentation. The typical clinical profile of the apneic patient is an middle aged (50-55 years) obese male, snoring and drowsy. Moreover, OSAS is a risk factor for hypertension independent of obesity (2, 3) and it is now clear evidence that untreated apnea patients have high cardiovascular morbidity / mortality (CVM) higher than subjects treated with CPAP (4-6).

Clinically, excessive daytime sleepiness (EDS) is the main symptom (7) but the attentional and cognitive disorders (8.9), depression or simply a state of fatigue are other possible manifestations of OSAS. The impact on quality of life (QoL) (10-12) are significant and underestimated. The origins of this drowsiness are multiple: one finds the fragmentation of sleep (13,14), intermittent hypoxia, respiratory effort, obesity (15) and certain cytokines such as TNF-alpha and IL-6 involved in sleep regulation (16-19).

On the pathophysiology, the investigators find in the obstructive apneic oxidative stress (20-24) and systemic inflammation (25-27). CRP and levels of some cytokines (IL-1 beta, IL-6, IL-8 and TNF-alpha) are increased and their levels are correlated with the severity of disease as the increase of CVD (28-30 ). Intermittent hypoxia appears to play an essential role in the genesis of these abnormalities (31).

On the metabolic dysregulation of many coexist. Found abnormal fasting blood glucose, a state of insulin resistance, dyslipidemia, and hyperleptinemia. Insulin resistance increases with body weight independent of the index of apnea / hypopnea (AHI) (18, 32-34). Intermittent hypoxia appears to be the cause. Leptin secreted by adipocytes, regulates weight by controlling appetite and energy expenditure. The hyperleptinemia found in OSA is controversial. Obesity appears to be primarily responsible for some (36) while others suggest the role of nocturnal hypoxemia (37). In fact, it is more the state of leptin resistance that hyperleptinemia alone that seems to be involved.

Treatment with continuous positive airway pressure (CPAP) has clearly demonstrated its effectiveness to suppress apneas and sleep fragmentation associated. A meta-analysis (38) has confirmed the improvement of IDS by the PPC. However, in less severe forms, improving the SDE is less clear (39) and the PPC is sometimes not easily accepted, not tolerated and limiting its effectiveness is its poor compliance (40,41). From a pathophysiological point of view, CSF improves systemic inflammation (26,27) and diminishes the CVD (5.6). For cons, the metabolic dysregulation (insulin resistance, hyperleptinemia, dyslipidemia) are improving somewhat CPAP except in patients without obesity (42-44).

The dietary guidelines are essential for the management of this disease is the result for a large part of a healthy lifestyle deleterious. Weight loss, regular physical activity is also clearly recommended but unfortunately rarely performed and / or supported by our healthcare system. Few studies have focused on studying the effects of such treatment on sleep apneic patients. In normal subjects, the effects of exercise on sleep are described in a meta-analysis (45). The practice of regular physical activity endurance improves quality of sleep (45-47). Sleep latency is shorter, there is less change in stages and fewer awakenings and arousals from sleep. Unlike other studies show that in situations where physical activity is reduced (physical inactivity, obesity, or prolonged bed rest, for example) sleep deteriorates, breaks and daytime alertness decreases. The effect of exercise in OSAS (48,49) and especially the training in physical exercise (48) shows an improvement in sleep quality and reduction of awakenings and arousals from sleep and fewer respiratory events (IAH). Pathophysiological point of view, there is a decrease in concentrations of leptin (50-53) and inflammatory cytokines (54-55) in different populations of subjects (healthy, older, obese, or with heart failure). And the investigators know the effects of exercise on carbohydrate metabolism in particular (decreased insulin resistance).

And physical activity improves sleep quality in normal subjects while in parallel it would have an anti-inflammatory. For patients with severe OSAS, our hypothesis is to improve the quality of sleep (SLP rate) and a decrease in AHI and EDS through rehabilitation training (REE) associated with a comprehensive care (patient education, dietary, psychological, ...). On the pathophysiology, this improvement would be through a reduction of biological abnormalities associated with OSA are also markers of cardiovascular risk. Mainly metabolic disorders, oxidative stress and systemic inflammation.

Being tested
In-patient rehabilitation, Educational activities alone
Keywords
Obstructive Sleep Apnea/Hypopnea Syndrome, Exercise training program, Inflammation, Oxidative Stress, Resistance to insulin
Medical subject headings
Sleep Apnea, Obstructive, Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-patient rehabilitationBehavioural

    Also called Individualized exercise training, Educational activities, Dietary management

    Individualized exercise training (IET):

    Duration : 24 sessions during 4 weeks

    IET session (2h) contains:

    • 15' start warming up muscles
    • 30' muscle strengthening exercise for arms and abdominal muscles
    • 45' individualized cycle ergometer endurance training to the ventilatory threshold heart rate measured on the cardiopulmonary exercise test.
    • 15' stretching
    • 15' postural, movement and balance exercises IET session was controlled by a professional instructor using heart rate monitoring. Duration, intensity and attendance were recorded in a logbook.

    Educational activities (20h): the 8 themes are comparable to comparator arm. Dietary management: was performed by dietician to ensure that energy intakes are adjusted to energy expenditure. No restrictive diet was prescribe.

  • Educational activities aloneBehavioural

    Also called Educational activities

    Educational activities alone contains 10 sessions lasting 1:00 with 8 themes :

    • Physiological mechanisms of apneas/hypopneas
    • Effects of apneas/hypopneas on health (vascular morbidity/mortality and sleepiness)
    • Beneficials effects of CPAP and/or advanced mandibular orthosis
    • Description of sleep stages and physiological roles of sleep
    • Known effects of exercise on sleep and metabolism
    • Importance of good nutritional status and sleep hygiene on quality of life
    • How to apply theses lessons of rehabilitation in daily life
Study groups in NCT01362777
Study groupRoleWhat they receive
In-Patient RehabilitationExperimentalSessions of rehabilitation contains : * Individualized exercise training * Educational activities * Dietary advices
Receives: Behavioral: In-patient rehabilitation
Educational activities aloneActive comparatorOut-patient control arm contains only : -Educational activities
Receives: Behavioral: Educational activities alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delta of the Apnea/Hypopnea Index (AHI)between the two arms

    Comparing Delta of AHI 4 weeks (J0/J28) after starting the intervention (assessed by polysomnography at inclusion - end monitoring) between the two arms using the Student t test or Wilcoxon test if the distribution is not Gaussian.

    Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2011 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2010
  4. Study completionAug 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362777
Sponsor's protocol ID
UF062007
Acronym
Rehsolvas
Status last verified
Sep 2011
First submitted
26 May 2011
Last updated
20 Sep 2011
Results posted
No
Data monitoring committee
No

Publications

  • Desplan M, Mercier J, Sabate M, Ninot G, Prefaut C, Dauvilliers Y. A comprehensive rehabilitation program improves disease severity in patients with obstructive sleep apnea syndrome: a pilot randomized controlled study. Sleep Med. 2014 Aug;15(8):906-12. doi: 10.1016/j.sleep.2013.09.023. Epub 2014 Apr 1.

    PubMed 24947878

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing In-patient rehabilitation and Educational activities alone in people with Sleep Apnea, Obstructive and Metabolic Syndrome, run by 5 Santé 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 6 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 20 Sep 2011. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Delta of the Apnea/Hypopnea Index (AHI)between the two arms (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01362777, which also lists 1 linked publication.

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 20 Sep 2011.

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