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

NCT01461486 | Completed DMC

• 1 other identifier: 1300/11
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Excessive Daytime Sleepiness

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

Secondary Outcomes (12)

• Evaluations of fatigue.

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral

• Evaluation of cognition.

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

• Evaluation of depression.

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.

• Evaluation of quality of life.

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral

• Evaluation of inflammation.

  From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral

Study Arms (3)

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

Intervention group

Device: Continuous Positive Airway Pressure (CPAP)

Oral Appliance (BRD)

ACTIVE COMPARATOR

Intervention group

Device: Oral Appliance (BRD)

Hygiene sleep care

NO INTERVENTION

Control group

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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

Also known as: Resmed (trademark). Autoset Vantage - fixed pressure.

Continuous Positive Airway Pressure

Oral Appliance (BRD) DEVICE

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

Also known as: Brazilian Dental Appliance (BRD).

Oral Appliance (BRD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32964829 DERIVED

• 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.

  PMID: 30077018 DERIVED

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 28, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

BR (1)