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

NCT ID: NCT01461486

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2019-11-30

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.

Conditions

Mild Obstructive Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Positive Airway Pressure

Intervention group

Group Type: ACTIVE_COMPARATOR

Continuous Positive Airway Pressure (CPAP)

Intervention Type: DEVICE

The device is a flow generator used to open the airway during sleep.

Oral Appliance (BRD)

Intervention group

Group Type: ACTIVE_COMPARATOR

Oral Appliance (BRD)

Intervention Type: DEVICE

The device increases the volume of the airway by mandibular traction.

Hygiene sleep care

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Positive Airway Pressure (CPAP)

The device is a flow generator used to open the airway during sleep.

Intervention Type: DEVICE

Oral Appliance (BRD)

The device increases the volume of the airway by mandibular traction.

Intervention Type: DEVICE

Other Intervention Names

Resmed (trademark). Autoset Vantage - fixed pressure.; Brazilian Dental Appliance (BRD).

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Lia Azeredo-Bittencourt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Guimaraes TM, Poyares D, Oliveira E Silva L, Luz G, Coelho G, Dal Fabbro C, Tufik S, Bittencourt L. The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment. J Clin Sleep Med. 2021 Feb 1;17(2):149-158. doi: 10.5664/jcsm.8822.

Reference Type: DERIVED

PMID: 32964829 (View on PubMed)

M Guimaraes 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.

Reference Type: DERIVED

PMID: 30077018 (View on PubMed)

Other Identifiers

1300/11

Identifier Type: -

Identifier Source: org_study_id