An interventional study of Group C-Postural device activated and Group B-Postural device no activated in OSA, sponsored by Hospital Universitario Araba. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by Hospital Universitario Araba · Not applicable, Interventional, and Treatment
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).
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.
Hospital Universitario Araba is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General recommendation not sleeping in supine position without the postural device
Behavioral: Group A-General Recommendation
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Device: Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Device: Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Also known as: Intervention
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Also known as: Placebo
General recommendation not sleeping in supine position
Also known as: Control
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).
Time frame: three month
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).
Time frame: 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).
Time frame: three month
Side effects
To determine the side effects.
Time frame: three month
Reduction of snoring
To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).
Time frame: 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.
Time frame: at baseline and at three month of follow-up
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure.
Time frame: three month
Anthropometric variables (Body mass index)
Body mass index
Time frame: 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).
Time frame: at baseline and at three month of follow-up
Ran from Sep 2015 to primary completion in Apr 2018, 31 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Araba