SLEEP APNEA SYNDROMENCT02482480
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
A study testing Exercise in people with SLEEP APNEA SYNDROME, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Study objetives : The aim of this study is to assess the impact of a combined therapy treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on symptoms and quality of life in patients with OSAS, as an alternative or addition to therapeutic treatment with nocturnal CPAP. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- SLEEP APNEA SYNDROME
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Aug 2015
- 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 20 to 85 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)
Who cannot join
- BMI > 40
- Concomitant heart disease, stroke or severe neuromuscular with medical judgment not doing exercise.
- Musculoskeletal disorders that impede the realization of the exercises
- Sleepiness affects your physical or occupational functioning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Comprehensive Management Program for the Treatment of Obstructive Sleep Apnea Syndrome
Study objetives : The aim of this study is to assess the impact of a combined therapy treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on symptoms and quality of life in patients with OSAS, as an alternative or addition to therapeutic treatment with nocturnal CPAP.
Read the detailed description
The obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction of the upper airway during sleep. OSAS is associated with a wide range of health consequences such as daytime sleepiness, cognitive impairment and metabolic and cardiovascular diseases. In Spain the prevalence of this disease is 3 to 6%, constituting a public health problem. The recommended first line treatment for OSAS is continuous positive pressure airway (CPAP).
Physical exercise has been shown to ameliorate the consequences of OSAS such as cardiovascular disease, glucose intolerance and fatigue. Scientific studies have shown that vigorous physical activity is associated with a decrease in the prevalence of OSAS, improved sleep efficiency and the Epworth Sleepiness Scale.
Moreover, recent evidence has shown that oropharyngeal exercises can be useful in the treatment of OSAS decreasing neck circumference, snoring, subjective sleepiness and AHI as well as improving the quality of life and saturation oxygen.
The 60-70% of patients with OSAS is overweight or obese showing that a high body mass index (BMI) is an independent risk factor for the occurrence of OSAS. Many studies have shown that weight loss is associated with significant reduction in AHI.
However, despite the scientific evidence to justify the inclusion of these modalities, there is no study that has analyzed the impact of performing together all these interventions. It is expected that the combination can produce a cumulative effect that impacts significantly on improving indicators of OSAS.
The investigators will include patients with a recent diagnosis of moderate or severe OSA. Patients will be randomized to interventional or control group.
Patients included in the study will be followed for almost three months and they will be examined at baseline and after time of follow-up or intervention.
- Conditions
- SLEEP APNEA SYNDROME
- Being tested
- Exercise, Control
- Keywords
- SLEEP, APNEA, EXERCISE
- Medical subject headings
- Sleep Apnea Syndromes, Apnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education
ControlOther
Dietary and general recommendations
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Participants followed a 8-week intervention program with a total of 24 sessions (12 of those were supervised). The aim of the supervision was to increase the adherence to the treatment and to control the compliance of patients. General physical activity consisted in walking along previously standardized urban parks designed for the urban EPOC training project (Arbillaga-Etxarri et al, 2016). The duration of walking were 30 minutes. The physiotherapist supervised the accomplishment of other activities such as oropharyngeal exercises and diet control.
Oropharyngeal exercises:
1. Expiratory muscle strength training (EMST):
2. Masako Manoeuvre
3. Shaker Head Lift:
4. Facial exercise Receives: Other: Exercise |
| Control Group | Sham comparator | Control group participants only received general recommendations regarding general physical activity, diet and sleep hygiene. After 8-weeks of control, they were re-evaluated with the same evaluation test used in the beginning of the study period. Recommendations for general physical activity were walking during 30 minutes at least 3 times a week maintaining the greatest possible pace. Also, control group patients received the same diet control document as intervention group and verbal advice for sleep hygiene. Approximately 1 month after enrolment, a follow-up phone call was completed were we also informed about the new re-evaluation data. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hipopnea index (AHI)
Measured: 10 weeks
Secondary outcomes (4)
OSA symtoms and quality of life
Epworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)
Measured: 10 weeks
Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband
Measured: 10 weeks
Distance walking in the Six minute walking Test
Measured: 10 weeks
Anxiety and depression on the Hospital Anxiety and Depression questionnaire
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEEP APNEA SYNDROMEStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M. Montserrat, Hospital Clinic of Barcelona
- Investigators
- Rodrigo Torres, MSc, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482480
- Sponsor's protocol ID
- SEPAR-ALAT-2014
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Comprehensive Management Program for the Treatment of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02482480
- Acronym / sponsor ID
- SEPAR-ALAT-2014
- Conditions
- SLEEP APNEA SYNDROME
- Keywords
- SLEEP, APNEA, EXERCISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Jun 2015 (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.
Study objetives : The aim of this study is to assess the impact of a combined therapy treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on symptoms and quality of life in patients with OSAS, as an alternative or addition to therapeutic treatment with nocturnal CPAP.
Detailed description
The obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction of the upper airway during sleep. OSAS is associated with a wide range of health consequences such as daytime sleepiness, cognitive impairment and metabolic and cardiovascular diseases. In Spain the prevalence of this disease is 3 to 6%, constituting a public health problem. The recommended first line treatment for OSAS is continuous positive pressure airway (CPAP).
Physical exercise has been shown to ameliorate the consequences of OSAS such as cardiovascular disease, glucose intolerance and fatigue. Scientific studies have shown that vigorous physical activity is associated with a decrease in the prevalence of OSAS, improved sleep efficiency and the Epworth Sleepiness Scale.
Moreover, recent evidence has shown that oropharyngeal exercises can be useful in the treatment of OSAS decreasing neck circumference, snoring, subjective sleepiness and AHI as well as improving the quality of life and saturation oxygen.
The 60-70% of patients with OSAS is overweight or obese showing that a high body mass index (BMI) is an independent risk factor for the occurrence of OSAS. Many studies have shown that weight loss is associated with significant reduction in AHI.
However, despite the scientific evidence to justify the inclusion of these modalities, there is no study that has analyzed the impact of performing together all these interventions. It is expected that the combination can produce a cumulative effect that impacts significantly on improving indicators of OSAS.
The investigators will include patients with a recent diagnosis of moderate or severe OSA. Patients will be randomized to interventional or control group.
Patients included in the study will be followed for almost three months and they will be examined at baseline and after time of follow-up or intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: ExerciseParticipants followed a 8-week intervention program with a total of 24 sessions (12 of those were supervised). The aim of the supervision was to increase the adherence to the treatment and to control the compliance of patients. General physical activity consisted in walking along previously standardized urban parks designed for the urban EPOC training project (Arbillaga-Etxarri et al, 2016). The duration of walking were 30 minutes. The physiotherapist supervised the accomplishment of other activities such as oropharyngeal exercises and diet control. Oropharyngeal exercises: 1. Expiratory muscle strength training (EMST): 2. Masako Manoeuvre 3. Shaker Head Lift: 4. Facial exercise |
| Control Group | Sham comparator | Other: ControlControl group participants only received general recommendations regarding general physical activity, diet and sleep hygiene. After 8-weeks of control, they were re-evaluated with the same evaluation test used in the beginning of the study period. Recommendations for general physical activity were walking during 30 minutes at least 3 times a week maintaining the greatest possible pace. Also, control group patients received the same diet control document as intervention group and verbal advice for sleep hygiene. Approximately 1 month after enrolment, a follow-up phone call was completed were we also informed about the new re-evaluation data. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI > 15/h)
Key exclusion criteria (4 listed)
- BMI > 40
- Concomitant heart disease, stroke or severe neuromuscular with medical judgment not doing exercise.
- Musculoskeletal disorders that impede the realization of the exercises
- Sleepiness affects your physical or occupational functioning.
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 |
|---|---|---|
| ExerciseWalking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education | Other | Interventional group |
| ControlDietary and general recommendations | Other | Control Group |
Primary outcome
Apnea-hipopnea index (AHI)
Time frame: 10 weeks
4 secondary outcomes
OSA symtoms and quality of life
Time frame: 10 weeks
Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband
Time frame: 10 weeks
Distance walking in the Six minute walking Test
Time frame: 10 weeks
Anxiety and depression on the Hospital Anxiety and Depression questionnaire
Time frame: 10 weeks
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 18 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Rodrigo Torres, MSc principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with SLEEP APNEA SYNDROME, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 4 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 18 Mar 2016. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Apnea-hipopnea index (AHI) (time frame: 10 weeks). 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 18 Mar 2016.