Sleep Apnea, ObstructivePhase 1NCT01936038
Upper Airway Toning for Improve the Compliance of CPAP
A Phase 1 study testing CPAP and Upper Airway Toning for Improve the Compliance of CPAP in people with Sleep Apnea, Obstructive, run by Fisiolistic at 1 site in Spain.
Trial summary
The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens at night and consists of the interruption of airflow for more than five seconds. His current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and therefore the level of compliance is key to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP and Upper Airway Toning for Improve the Compliance of CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Feb 2014
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with OSA using CPAP
Who cannot join
- Neurological Patients
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fisiolistic
L'Hospitalet de Llobregat, Barcelona, 08901
Anna Maria Bague Cruz, Physio, 34 647676131, annabague@hotmail.com
About this study
Official title: Effectiveness of Upper Airway Toning as Adjuvant Treatment in the Former Period of Adaptation of the Continuous Positive Airway Pressure
The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens at night and consists of the interruption of airflow for more than five seconds. His current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and therefore the level of compliance is key to patient improvement. Many patients don´t tolerate CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These techniques are: oropharyngeal exercises executed actively by the patient for the muscle toning of the upper airways, electrostimulation of the muscles in the floor of the mouth, correction of the tongue position, nasal and bronchial fogging, execution of respiratory gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical column,and massage in the diaphragm. All the techniques together seek for a greater or lesser impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal reflux, the excessive accumulation of secretions in the upper and lower airways, the obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All these disfunctions will make easier for the patient to show side effects in the use of CPAP. There will be a double-blind randomized controlled study with 110 individuals. One group will follow the conventional medical treatment with CPAP and the other group medical treatment plus Upper Airway Toning. After six months, the mean improvement between the two groups will be compared.
Read the detailed description
OBJECTIVES
Main objective: To increase the percentage of Nasal Continuous Positive Airway Pressure (nCPAP) compliance.
Secondary objectives:
- To increase the CPAP's tolerance.
- To decrease the CPAP's pressure.
- To decrease the daytime sleepiness.
- To increase the quality of life related to sleep.
- To assess the level of subjective utility of CPAP by the patient.
METHODOLOGY
Type of study: Controlled randomized simple blind study
Randomization of groups
Once the patient is into the study (because s/he has the inclusion criteria and has signed up the informed consent), an opaque envelope is opened in order to know the assigned group.The envelopes are consecutively numbered and the assigned group is randomized through the software.
- Group 1 or control group: 55 subjects undergo the CPAP treatment.
- Group 2 or study group: 55 subjects undergo the CPAP treatment and Upper Airway Toning.
Homogeneity of groups:
Investigators check out the homogeneity of groups in baseline:
Specific features: Neck circumference, presence or lack of nasal clinic, presence or lack of nasal structural alteration, age, gender, weight, height, BMI, smoking habits.
Polysomnographic parameters: Number of apnea, number of hypo-apneas and Apnea Hypopnea Index (AHI).
Symptoms: Presence or lack of severe comorbidities, level of daily hyper-somnolence, presence of insomnia
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP, Upper Airway Toning for Improve the Compliance of CPAP
- Keywords
- CPAP, Upper Airway Toning, Obstructive Sleep Apnoea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPOther
CPAP
Upper Airway Toning for Improve the Compliance of CPAPProcedure or surgery
Upper Airway Toning for Improve the Compliance of CPAP
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | CPAP Receives: Other: CPAP |
| EXPERIMENTAL GROUP | Experimental | Upper Airway Toning for Improve the Compliance of CPAP Receives: Other: CPAP; Procedure: Upper Airway Toning for Improve the Compliance of CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP compliance
nominal variable
Measured: 3 months
Secondary outcomes (1)
Sleep Apnea Quality of Life Index (SAQLI) Test
Test of quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisiolistic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduard Estelle, Principal investigator, Hospital Universitari General de CatalunyaAnna Bagué, Study chair, FisiolísticXavier Gironés, Study chair, Universitat Internacional de CatalunyaMontserrat Girabent, Study chair, Universitat General de CatalunyaEduard Estivill, Study chair, Clínica DexeusFrancesc Segarra, Study chair, Hospital Universitari General de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936038
- Sponsor's protocol ID
- Upper Airway Toning - 001
- Status last verified
- Sep 2013
- First submitted
- 24 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Upper Airway Toning as Adjuvant Treatment in the Former Period of Adaptation of the Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT01936038
- Acronym / sponsor ID
- Upper Airway Toning - 001
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- CPAP, Upper Airway Toning, Obstructive Sleep Apnoea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- FisiolisticUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Sep 2013 (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.
The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens at night and consists of the interruption of airflow for more than five seconds. His current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and therefore the level of compliance is key to patient improvement. Many patients don´t tolerate CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These techniques are: oropharyngeal exercises executed actively by the patient for the muscle toning of the upper airways, electrostimulation of the muscles in the floor of the mouth, correction of the tongue position, nasal and bronchial fogging, execution of respiratory gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical column,and massage in the diaphragm. All the techniques together seek for a greater or lesser impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal reflux, the excessive accumulation of secretions in the upper and lower airways, the obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All these disfunctions will make easier for the patient to show side effects in the use of CPAP. There will be a double-blind randomized controlled study with 110 individuals. One group will follow the conventional medical treatment with CPAP and the other group medical treatment plus Upper Airway Toning. After six months, the mean improvement between the two groups will be compared.
Detailed description
OBJECTIVES
Main objective: To increase the percentage of Nasal Continuous Positive Airway Pressure (nCPAP) compliance.
Secondary objectives:
- To increase the CPAP's tolerance.
- To decrease the CPAP's pressure.
- To decrease the daytime sleepiness.
- To increase the quality of life related to sleep.
- To assess the level of subjective utility of CPAP by the patient.
METHODOLOGY
Type of study: Controlled randomized simple blind study
Randomization of groups
Once the patient is into the study (because s/he has the inclusion criteria and has signed up the informed consent), an opaque envelope is opened in order to know the assigned group.The envelopes are consecutively numbered and the assigned group is randomized through the software.
- Group 1 or control group: 55 subjects undergo the CPAP treatment.
- Group 2 or study group: 55 subjects undergo the CPAP treatment and Upper Airway Toning.
Homogeneity of groups:
Investigators check out the homogeneity of groups in baseline:
Specific features: Neck circumference, presence or lack of nasal clinic, presence or lack of nasal structural alteration, age, gender, weight, height, BMI, smoking habits.
Polysomnographic parameters: Number of apnea, number of hypo-apneas and Apnea Hypopnea Index (AHI).
Symptoms: Presence or lack of severe comorbidities, level of daily hyper-somnolence, presence of insomnia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: CPAPCPAP |
| EXPERIMENTAL GROUP | Experimental | Other: CPAP, Procedure: Upper Airway Toning for Improve the Compliance of CPAPUpper Airway Toning for Improve the Compliance of CPAP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with OSA using CPAP
Key exclusion criteria (1 listed)
- Neurological Patients
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 |
|---|---|---|
| CPAPCPAP | Other | Control Group, EXPERIMENTAL GROUP |
| Upper Airway Toning for Improve the Compliance of CPAPUpper Airway Toning for Improve the Compliance of CPAP | Procedure or surgery | EXPERIMENTAL GROUP |
Primary outcome
CPAP compliance
Time frame: 3 months
nominal variable
1 secondary outcome
Sleep Apnea Quality of Life Index (SAQLI) Test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Eduard Estelle principal investigator
Hospital Universitari General de Catalunya
Anna Bagué study chair
Fisiolístic
Xavier Gironés study chair
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPAP and Upper Airway Toning for Improve the Compliance of CPAP in people with Sleep Apnea, Obstructive, run by Fisiolistic 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 1 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 5 Sep 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eduard Estelle, Doctor (647676131, annabague@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP compliance (time frame: 3 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 Sep 2013.