An observational study in Sleep Apnea, Obstructive, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
Sleep is an important factor that influences long-term quality of life with known health consequences. Obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public health problem. Treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. Mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. There is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. This pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.
Design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. The care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. Demographic and anthropometric data will be collected. The dental status of the temporo-mandibular joint will be assessed. Radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 50 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 74 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who come to the Multidisciplinary sleep unit of the Fundación Jiménez Díaz with suspicion of Obstructive sleep apnea and who present an Apnea Hypopnea Index greater than five
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:
The multidisciplinary sleep unit assessment and follow-up protocol will be followed for this group of patients based on the Spanish Clinical Practice Guideline of the Spanish Sleep Society (SES) on the use of mandibular advancement devices in the treatment of patients with obstructive sleep apnea
mandibular advancement device on sleep quality
Tolerability and efficacy of treatment with a mandibular advancement device (MAD) on sleep quality in patients with Obstructive Sleep Apnea (OSA) measured by the ambulatory circadian monitoring device.
Time frame: 3 years
ambulatory circadian monitoring device
To evaluate improvement in sleep quality with mandibular advancement devices measured by fragmentation and stability of sleep by the circadian monitoring sensor.
Time frame: 3 years
home sleep apnea test
To evaluate the number of residual apneic breaths measured by home home sleep apnea test
Time frame: 3 years
Obstructive sleep apnea severity
Evaluate the severity by home sleep apnea test
Time frame: 3 years
questionnaire SF-12
multidimensional health related quality of life
Time frame: 3 years
questionnaire EuroQoL
standardized non-disease specific instrument to describe and value health-related quality of life
Time frame: 3 years
questionnaire iPAQ
International Physical Activity Questionnaire
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Sep 2022, 20 months.
Of 259 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's 20 months is below that.
Counting every sponsor, half of 294 studies reached it within 30 months; a quarter within 15 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz