DAMOSA
Impact of Treatment With Mandibular Advancement Device (MAD) on Sleep Quality in Patients With Obstructive Sleep Apnea (OSA)
Sponsor study identifier
observational
50
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)September 30, 2022
Actual (reported)January 30, 2023
Actual (reported)December 13, 2023
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
3 years
home sleep apnea test
To evaluate the number of residual apneic breaths measured by home home sleep apnea test
3 years
Obstructive sleep apnea severity
3 years
questionnaire SF-12
3 years
questionnaire EuroQoL
3 years
questionnaire iPAQ
3 years
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Maria Fernanda Troncoso Acevedo
Madrid, 28004, Spain
blood
50 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2023
First Posted
December 13, 2023
Study Start
January 1, 2021
Actual (reported)Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 13, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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