Sleep ApneaPASOSNCT03086850
Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
A study testing Promotion of daily physical activity with a pedometer and Conventional treatment in people with Sleep Apnea, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA). Study patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Promotion of daily physical activity with a pedometer and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2025to 3 Nov 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 30 to 80 years
- Diagnosis of mild-moderate obstructive sleep apnea [apnea-hypopnea index 5-30 h-1] by polysomnography or respiratory polygraphy
- Predominance of obstructive events (> 80%)
- Signature of informed consent
Who cannot join
- Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease.
- Evidence of central apneas, hypoventilation syndrome or respiratory failure
- Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease.
- Neurological or osteoarticular limitation that prevents ambulation.
- Professional drivers or occupational risk or respiratory
- Previous treatment with CPAP
- Participation in another clinical trial in the 30 days prior to randomization.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Francisco Garcia-Rio
Madrid, 28046
Francisco Garcia-Rio, MD, +34914269802, fgr01m@gmail.com
Begoña Sánchez-Sánchez, MD
About this study
Official title: Randomized, Parallel and Controled Clinical Trial to Assess the Effect of the Physical Activity Promotion During 12 Months on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA).
Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)].
Read more
Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.
Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps).
Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.
- Conditions
- Sleep Apnea
- Being tested
- Promotion of daily physical activity with a pedometer, Conventional treatment
- 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.
Promotion of daily physical activity with a pedometerBehavioural
Patients will receive an ONwalk 100 pedometer (GEONAUTE, France) and will be instructed how to use it. They will be encouraged to be more active by using the pedometer to measure the number of steps walked daily and to record this in a diary, together with any information related to their clinical condition. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol:
- <6000 steps/day: increase by 3000 steps/day
- 6000 - 10000 steps/day: reach 10000 steps/day
- > 10000 steps/day: maintain or increase steps
Conventional treatmentOther
Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer | Experimental | Standard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer Receives: Behavioral: Promotion of daily physical activity with a pedometer; Other: Conventional treatment |
| Conventional management | Active comparator | Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
To compare the apnea-hypopnea index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Secondary outcomes (10)
Nocturnal oxyhemoglobin saturation
To compare the nocturnal oxyhemoglobin saturation of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Physical activity level
To compare the physical activity level of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Baseline determinants of physical activity
To relate the baseline physical activity performed by patients with mild-moderate sleep apnea with their sleep parameters
Measured: 12 months
Body composition
To compare the fat free mass index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Diurnal sleepiness
To compare the Epworth sleepiness scale of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Functional impact
To compare the total score of the Functional Outcomes of Sleep Questionnaire of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Systematic Coronary Risk Evaluation
To compare the Systematic Coronary Risk Evaluation of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Insulin sensitivity
To compare the HOMA index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Oxidative stress
To compare the plasmatic 8-isoprostane levels of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
Measured: 12 months
Systemic inflammation
To compare the plasmatic levels of IL-1beta, IL6, IL8 and TNF-alpha of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
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 posted22 Mar 2017
- Study start3 Apr 2025 (estimated)
- Primary completion3 Apr 2025 (estimated)
- Study completion3 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086850
- Sponsor's protocol ID
- HULP-2613
- Acronym
- PASOS
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2017
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel and Controled Clinical Trial to Assess the Effect of the Physical Activity Promotion During 12 Months on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03086850
- Acronym / sponsor ID
- PASOS / HULP-2613
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 3 Apr 2025 (estimated)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 3 Nov 2025 (estimated)
- First posted
- 22 Mar 2017 (actual)
- 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.
Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA).
Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)].
Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.
Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps).
Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer | Experimental | Behavioral: Promotion of daily physical activity with a pedometer, Other: Conventional treatmentStandard recommendations on healthy habits and lifestyle plus daily recording of steeps with a pedometer |
| Conventional management | Active comparator | Other: Conventional treatmentTreatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 30 to 80 years
- Diagnosis of mild-moderate obstructive sleep apnea [apnea-hypopnea index 5-30 h-1] by polysomnography or respiratory polygraphy
- Predominance of obstructive events (> 80%)
- Signature of informed consent
Key exclusion criteria (7 listed)
- Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease.
- Evidence of central apneas, hypoventilation syndrome or respiratory failure
- Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease.
- Neurological or osteoarticular limitation that prevents ambulation.
- Professional drivers or occupational risk or respiratory
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 |
|---|---|---|
| Promotion of daily physical activity with a pedometerPatients will receive an ONwalk 100 pedometer (GEONAUTE, France) and will be instructed how to use it. They will be encouraged to be more active by using the pedometer to measure the number of steps walked daily and to record this in a diary, together with any information related to their clinical condition. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol: * <6000 steps/day: increase by 3000 steps/day * 6000 - 10000 steps/day: reach 10000 steps/day * > 10000 steps/day: maintain or increase steps | Behavioural | Pedometer |
| Conventional treatmentTreatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle. | Other | Conventional management, Pedometer |
Primary outcome
Apnea-hypopnea index
Time frame: 12 months
To compare the apnea-hypopnea index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
10 secondary outcomes
Nocturnal oxyhemoglobin saturation
Time frame: 12 months
Physical activity level
Time frame: 12 months
Baseline determinants of physical activity
Time frame: 12 months
Body composition
Time frame: 12 months
Diurnal sleepiness
Time frame: 12 months
Functional impact
Time frame: 12 months
Systematic Coronary Risk Evaluation
Time frame: 12 months
Insulin sensitivity
Time frame: 12 months
Oxidative stress
Time frame: 12 months
Systemic inflammation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of daily physical activity with a pedometer and Conventional treatment in people with Sleep Apnea, run by Hospital Universitario La Paz 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Garcia-Rio, MD (+34914269802, fgr01m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (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 3 Mar 2023.