OSAPOSTURALNCT03336515
Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
A study testing Group C-Postural device activated, Group B-Postural device no activated and Group A-General Recommendation in people with OSA, run by Hospital Universitario Araba at 1 site in Spain.
Trial summary
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- Group C-Postural device activated, Group B-Postural device no activated and Group A-General Recommendation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2015to 27 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years old with diagnosis of positional OSA by PSG.
- Apnea-Hypopnea index (AHI) ≥ 5
- Apnea-Hypopnea index (AHI) in supine position doubling AHI in not supine position
- Time in supine position ≥ 20% total sleep time.
- Total sleep time at least 180 minutes
- Not received any treatment for OSA in the last four weeks before inclusion at the study (Except hygienic measures)
- Written informed consent signed.
Who cannot join
- Important problems of physical mobility
- Body mass index > 40kg/m²
- Presence of any previously diagnosed sleep disorders (narcolepsy, insomnia...) or difficulty in adopting a standard sleeping position
- Cognitive impairment, professional driver, use dangerous machinery, workers in three shifts, pregnant women or patients with severe disease.
- Patients with severe cardiovascular and/or respiratory comorbidity
- Excessive daytime sleepiness, Epworth scale >12
- Treatment with psychotropic drugs, central stimulant drugs, antidepressants, consumers of illegal drugs or consume > 80 grams of ethanol per day.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).
Read the detailed description
PURPOSE:
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).
The postural device is a vibratil device of 5x3 cm and a weight of about 30 grams integrating an accelerometer, a vibration and other sensors. The device is placed on the patient's forehead and when the device detects that the patient is in the supine position for 30 seconds or more, it starts a vibration, with increasing intensity, which ceases when the patient moves to lateral.
METHODOLOGY: DESIGN: A multicenter, randomized parallel study controlled by placebo. It will include patients with diagnosis of positional OSA in the Sleep Units of the Hospital Universitario Araba and Hospital Arnau de Vilanova de Lleida. These patients will be randomized to three groups: Group A: General recommendation not sleeping in supine position; Group B: General recommendation not sleeping in supine position and the device without any activation (placebo); Group C: General recommendation not sleeping in supine position and the device activated (intervention group).
Patients will undergo a basal conventional polysomnography (PSG) and after 12 weeks of treatment. In addition all patients will be visited at 1, 4, 8 and 12 weeks.
PRIMARY OUTCOME: Validity of the effectiveness of a vibrating postural device in reduce the respiratory events in patients with positional Obstructive Sleep Apnea . SECONDARY OUTCOMES: To determine the effectiveness of the device for: 1) To reduce the time spent in supine position; 2)To maintain the quantity and the quality of sleep; 3) The side effects ; 4) Reduction of snoring; 5) Cost-effectiveness analysis.
- Conditions
- OSA
- Being tested
- Group C-Postural device activated, Group B-Postural device no activated, Group A-General Recommendation
- Keywords
- Positional Obstructive Sleep Apnea, Postural Device, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C-Postural device activatedDevice
Also called Intervention
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Group B-Postural device no activatedDevice
Also called Placebo
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Group A-General RecommendationBehavioural
Also called Control
General recommendation not sleeping in supine position
| Study group | Role | What they receive |
|---|---|---|
| Group A-General Recommendation | Other | General recommendation not sleeping in supine position without the postural device Receives: Behavioral: Group A-General Recommendation |
| Group B-Postural device no activated | Placebo comparator | General recommendation not sleeping in supine position and the postural device without any activation (placebo) Receives: Device: Group B-Postural device no activated |
| Group C-Postural device activated | Experimental | General recommendation not sleeping in supine position and the postural device activated (intervention group). Receives: Device: Group C-Postural device activated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
The effectiveness of the treatment will be measured by polysomnography (PSG), comparing the results of the basal PSG with the results of the final PSG (3 month), based on the results of the apnea hypopnea index (AHI).
Measured: three month
Secondary outcomes (8)
Reduce the time spent in supine position
To determine the effectiveness of the device for to reduce the time spent in supine position, measured by polysomnography, comparing the results of the basal PSG with the results of the final PSG (3 month).
Measured: three month
Maintain the quantity and the quality of sleep
To determine the effectiveness of the device for to maintain the quantity and the quality of sleep, measured by polysomnography (PSG).
Measured: three month
Side effects
To determine the side effects.
Measured: three month
Reduction of snoring
To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).
Measured: three month
Epworth Sleepiness Scale
The Epworth Sleepiness Scale score (the sum of 8 items score, 0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness.
Measured: at baseline and at three month of follow-up
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure.
Measured: three month
Anthropometric variables (Body mass index)
Body mass index
Measured: three month
Quality of life (EuroQOL test)
Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of wich is defined with three levels of severity, as measured by a Likert scale type(no problems, some problems and many problems or inability to activity).
Measured: at baseline and at three month of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Sep 2015
- Primary completion27 Apr 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OSAStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Araba
- Sponsor type
- University, hospital or other
- Collaborators
- SIBEL SL, Hospital Arnau de Vilanova, Instituto de Salud Carlos III, Instituto Vasco de Investigación Sanitaria (BIOEF)
- Responsible party
- Principal investigator, Joaquin Duran-Cantolla, MD, Hospital Universitario Araba
- Investigators
- Joaquin Duran-Cantolla, MD, Principal investigator, Hospital Universitario ArabaJordi Rigau, Ing, Principal investigator, Sibel SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336515
- Sponsor's protocol ID
- 2014142
- Acronym
- POSTURAL
- Status last verified
- Oct 2019
- First submitted
- 1 Dec 2015
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
PubMed 11254524Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Duran-Cantolla J, Mar J, de La Torre Munecas G, Rubio Aramendi R, Guerra L. [The availability in Spanish public hospitals of resources for diagnosing and treating sleep apnea-hypopnea syndrome]. Arch Bronconeumol. 2004 Jun;40(6):259-67. doi: 10.1016/s1579-2129(06)70096-9. Spanish.
PubMed 15161592Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.
PubMed 6740055Oksenberg A, Silverberg DS, Arons E, Radwan H. Positional vs nonpositional obstructive sleep apnea patients: anthropomorphic, nocturnal polysomnographic, and multiple sleep latency test data. Chest. 1997 Sep;112(3):629-39. doi: 10.1378/chest.112.3.629.
PubMed 9315794Cartwright RD, Lloyd S, Lilie J, Kravitz H. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep. 1985;8(2):87-94. doi: 10.1093/sleep/8.2.87.
PubMed 4012159Jokic R, Klimaszewski A, Crossley M, Sridhar G, Fitzpatrick MF. Positional treatment vs continuous positive airway pressure in patients with positional obstructive sleep apnea syndrome. Chest. 1999 Mar;115(3):771-81. doi: 10.1378/chest.115.3.771.
PubMed 10084491van Maanen JP, Richard W, Van Kesteren ER, Ravesloot MJ, Laman DM, Hilgevoord AA, de Vries N. Evaluation of a new simple treatment for positional sleep apnoea patients. J Sleep Res. 2012 Jun;21(3):322-9. doi: 10.1111/j.1365-2869.2011.00974.x. Epub 2011 Oct 22.
PubMed 22017727Ravesloot MJ, van Maanen JP, Dun L, de Vries N. The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea-a review of the literature. Sleep Breath. 2013 Mar;17(1):39-49. doi: 10.1007/s11325-012-0683-5. Epub 2012 Mar 24.
PubMed 22441662Hidalgo-Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran-Carro J, Ullate J, Rigau J, Duran-Cantolla J; Spanish Sleep Network. Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial. BMJ Open Respir Res. 2023 Jun;10(1):e001503. doi: 10.1136/bmjresp-2022-001503.
PubMed 37349132Hidalgo Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran Carro J, Ullate J, Barbe F, Duran-Cantolla J; Spanish Sleep Network. New forehead device in positional obstructive sleep apnoea: a randomised clinical trial. Thorax. 2021 Sep;76(9):930-938. doi: 10.1136/thoraxjnl-2020-216167. Epub 2021 Apr 22.
PubMed 33888576
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
- ClinicalTrials.gov ID
- NCT03336515
- Acronym / sponsor ID
- POSTURAL / 2014142
- Conditions
- OSA
- Keywords
- Positional Obstructive Sleep Apnea, Postural Device, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hospital Universitario ArabaUniversity, hospital or other
- Collaborators
- SIBEL SL, Hospital Arnau de Vilanova, Instituto de Salud Carlos III, Instituto Vasco de Investigación Sanitaria (BIOEF)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 8 Nov 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.
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).
Detailed description
PURPOSE:
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).
The postural device is a vibratil device of 5x3 cm and a weight of about 30 grams integrating an accelerometer, a vibration and other sensors. The device is placed on the patient's forehead and when the device detects that the patient is in the supine position for 30 seconds or more, it starts a vibration, with increasing intensity, which ceases when the patient moves to lateral.
METHODOLOGY: DESIGN: A multicenter, randomized parallel study controlled by placebo. It will include patients with diagnosis of positional OSA in the Sleep Units of the Hospital Universitario Araba and Hospital Arnau de Vilanova de Lleida. These patients will be randomized to three groups: Group A: General recommendation not sleeping in supine position; Group B: General recommendation not sleeping in supine position and the device without any activation (placebo); Group C: General recommendation not sleeping in supine position and the device activated (intervention group).
Patients will undergo a basal conventional polysomnography (PSG) and after 12 weeks of treatment. In addition all patients will be visited at 1, 4, 8 and 12 weeks.
PRIMARY OUTCOME: Validity of the effectiveness of a vibrating postural device in reduce the respiratory events in patients with positional Obstructive Sleep Apnea . SECONDARY OUTCOMES: To determine the effectiveness of the device for: 1) To reduce the time spent in supine position; 2)To maintain the quantity and the quality of sleep; 3) The side effects ; 4) Reduction of snoring; 5) Cost-effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A-General Recommendation | Other | Behavioral: Group A-General RecommendationGeneral recommendation not sleeping in supine position without the postural device |
| Group B-Postural device no activated | Placebo comparator | Device: Group B-Postural device no activatedGeneral recommendation not sleeping in supine position and the postural device without any activation (placebo) |
| Group C-Postural device activated | Experimental | Device: Group C-Postural device activatedGeneral recommendation not sleeping in supine position and the postural device activated (intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years old with diagnosis of positional OSA by PSG.
- Apnea-Hypopnea index (AHI) ≥ 5
- Apnea-Hypopnea index (AHI) in supine position doubling AHI in not supine position
- Time in supine position ≥ 20% total sleep time.
- Total sleep time at least 180 minutes
Key exclusion criteria (7 listed)
- Important problems of physical mobility
- Body mass index > 40kg/m²
- Presence of any previously diagnosed sleep disorders (narcolepsy, insomnia...) or difficulty in adopting a standard sleeping position
- Cognitive impairment, professional driver, use dangerous machinery, workers in three shifts, pregnant women or patients with severe disease.
- Patients with severe cardiovascular and/or respiratory comorbidity
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 |
|---|---|---|
| Group C-Postural device activatedAlso: InterventionGeneral recommendation not sleeping in supine position and the postural device activated (intervention group). | Device | Group C-Postural device activated |
| Group B-Postural device no activatedAlso: PlaceboGeneral recommendation not sleeping in supine position and the postural device without any activation (placebo) | Device | Group B-Postural device no activated |
| Group A-General RecommendationAlso: ControlGeneral recommendation not sleeping in supine position | Behavioural | Group A-General Recommendation |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: three month
The effectiveness of the treatment will be measured by polysomnography (PSG), comparing the results of the basal PSG with the results of the final PSG (3 month), based on the results of the apnea hypopnea index (AHI).
8 secondary outcomes
Reduce the time spent in supine position
Time frame: three month
Maintain the quantity and the quality of sleep
Time frame: three month
Side effects
Time frame: three month
Reduction of snoring
Time frame: three month
Epworth Sleepiness Scale
Time frame: at baseline and at three month of follow-up
Blood pressure
Time frame: three month
Anthropometric variables (Body mass index)
Time frame: three month
Quality of life (EuroQOL test)
Time frame: at baseline and at three month of follow-up
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 3 Oct 2019.
- Background: PubMed 11254524Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 15161592Duran-Cantolla J, Mar J, de La Torre Munecas G, Rubio Aramendi R, Guerra L. [The availability in Spanish public hospitals of resources for diagnosing and treating sleep apnea-hypopnea syndrome]. Arch Bronconeumol. 2004 Jun;40(6):259-67. doi: 10.1016/s1579-2129(06)70096-9. Spanish.
- Background: PubMed 6740055Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.
- Background: PubMed 9315794Oksenberg A, Silverberg DS, Arons E, Radwan H. Positional vs nonpositional obstructive sleep apnea patients: anthropomorphic, nocturnal polysomnographic, and multiple sleep latency test data. Chest. 1997 Sep;112(3):629-39. doi: 10.1378/chest.112.3.629.
- Background: PubMed 4012159Cartwright RD, Lloyd S, Lilie J, Kravitz H. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep. 1985;8(2):87-94. doi: 10.1093/sleep/8.2.87.
- Background: PubMed 10084491Jokic R, Klimaszewski A, Crossley M, Sridhar G, Fitzpatrick MF. Positional treatment vs continuous positive airway pressure in patients with positional obstructive sleep apnea syndrome. Chest. 1999 Mar;115(3):771-81. doi: 10.1378/chest.115.3.771.
- Background: PubMed 22017727van Maanen JP, Richard W, Van Kesteren ER, Ravesloot MJ, Laman DM, Hilgevoord AA, de Vries N. Evaluation of a new simple treatment for positional sleep apnoea patients. J Sleep Res. 2012 Jun;21(3):322-9. doi: 10.1111/j.1365-2869.2011.00974.x. Epub 2011 Oct 22.
- Background: PubMed 22441662Ravesloot MJ, van Maanen JP, Dun L, de Vries N. The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea-a review of the literature. Sleep Breath. 2013 Mar;17(1):39-49. doi: 10.1007/s11325-012-0683-5. Epub 2012 Mar 24.
- Derived from this study: PubMed 37349132Hidalgo-Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran-Carro J, Ullate J, Rigau J, Duran-Cantolla J; Spanish Sleep Network. Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial. BMJ Open Respir Res. 2023 Jun;10(1):e001503. doi: 10.1136/bmjresp-2022-001503.
- Derived from this study: PubMed 33888576Hidalgo Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran Carro J, Ullate J, Barbe F, Duran-Cantolla J; Spanish Sleep Network. New forehead device in positional obstructive sleep apnoea: a randomised clinical trial. Thorax. 2021 Sep;76(9):930-938. doi: 10.1136/thoraxjnl-2020-216167. Epub 2021 Apr 22.
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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.
Joaquin Duran-Cantolla, MD principal investigator
Hospital Universitario Araba
Jordi Rigau, Ing principal investigator
Sibel SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group C-Postural device activated, Group B-Postural device no activated and Group A-General Recommendation in people with OSA, run by Hospital Universitario Araba 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 7 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: finished, as of the sponsor's last update on 3 Oct 2019. 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-Hypopnea Index (AHI) (time frame: three month). 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 NCT03336515, which also lists 11 linked publications.
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 Oct 2019.