Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea

Mild Obstructive Sleep Apnea Syndrome Clinical Trial

— OSAS  

Official title:

Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461486
• Other study ID #: 1300/11
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Both genders;

• body mass index lower than 35Kg/m2;

• age between 18 and 65 years old;

• polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.

Exclusion Criteria:

• Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);

• temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);

• excessive use of alcohol and psychoactive drugs;

• clinical, neurological or psychiatric decompensated diseases;

• others sleep diseases and previous obstructive sleep apnea treatment.

Related Conditions & MeSH terms

• Apnea
• Mild Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure (CPAP)
The device is a flow generator used to open the airway during sleep.
• Oral Appliance (BRD)
The device increases the volume of the airway by mandibular traction.

Locations

Country	Name	City	State
Brazil	Associação Fundo de Incentivo à Pesquisa	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excessive Daytime Sleepiness		From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary	Evaluations of fatigue.		From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of cognition.	Performance Vigilance Test (PVT)	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary	Evaluation of depression.	Beck Depression Inventory - BDI	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary	Evaluation of quality of life.		From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of inflammation.	Blood analysis for inflammatory.	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of blood pressure.	Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of sexual dysfunction.		From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of anxiety	Beck Anxiety Inventory - BAI	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of metabolism	Blood analysis for metabolism	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Secondary	Evaluation of hormonal alterations.	Blood analysis for hormonal alterations.	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary	Evaluation of heart rate variability	Assessment of heart rate variability.	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary	Evaluation of endothelial disfunction.	Assessment of endothelial disfunction.	From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.