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

• ClinicalTrials.gov Identifier: NCT01461486
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Last Update Posted: November 13, 2019
• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Information provided by (Responsible Party): Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mild Obstructive Sleep Apnea Syndrome	Device: Continuous Positive Airway Pressure (CPAP); Device: Oral Appliance (BRD)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study
• Study Start Date: October 2011
• Actual Primary Completion Date: November 2019
• Actual Study Completion Date: November 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Continuous Positive Airway Pressure; Intervention group	Device: Continuous Positive Airway Pressure (CPAP); The device is a flow generator used to open the airway during sleep.; Other Name: Resmed (trademark). Autoset Vantage - fixed pressure.
Active Comparator: Oral Appliance (BRD); Intervention group	Device: Oral Appliance (BRD); The device increases the volume of the airway by mandibular traction.; Other Name: Brazilian Dental Appliance (BRD).
No Intervention: Hygiene sleep care; Control group

Outcome Measures

Primary Outcome Measures :

1. Excessive Daytime Sleepiness [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]

Secondary Outcome Measures :

1. Evaluations of fatigue. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
2. Evaluation of cognition. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
   Performance Vigilance Test (PVT)
3. Evaluation of depression. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
   Beck Depression Inventory - BDI
4. Evaluation of quality of life. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
5. Evaluation of inflammation. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
   Blood analysis for inflammatory.
6. Evaluation of blood pressure. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
   Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
7. Evaluation of sexual dysfunction. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
8. Evaluation of anxiety [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
   Beck Anxiety Inventory - BAI
9. Evaluation of metabolism [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
   Blood analysis for metabolism
10. Evaluation of hormonal alterations. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
    Blood analysis for hormonal alterations.
11. Evaluation of heart rate variability [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
    Assessment of heart rate variability.
12. Evaluation of endothelial disfunction. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
    Assessment of endothelial disfunction.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Associação Fundo de Incentivo à Pesquisa

São Paulo, SP, Brazil, 04024-002

Sponsors and Collaborators

Associação Fundo de Incentivo à Pesquisa

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

M Guimarães T, Bittencourt L, P Luz G, O Silva L, Burke P, Coelho G, Milani A, Badke L, Togeiro S, Tufik S, Poyares D. Association between nondipping pattern and EndoPAT signal in patients with mild obstructive sleep apnea. Sleep Med. 2018 Nov;51:9-14. doi: 10.1016/j.sleep.2018.05.041. Epub 2018 Jun 27.

• Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Professor, Associação Fundo de Incentivo à Pesquisa
• ClinicalTrials.gov Identifier: NCT01461486
• Other Study ID Numbers: 1300/11
• First Posted: October 28, 2011
• Last Update Posted: November 13, 2019
• Last Verified: November 2019

Keywords provided by Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa:

Continuous positive airway pressure; Oral appliance; mild Obstructive Sleep Apnea Syndrome

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases