Clinical trial NCT01461486: Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Obstructive Sleep Apnea Syndrome
Keywords: Continuous positive airway pressure
Oral appliance
mild Obstructive Sleep Apnea Syndrome
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Excessive Daytime Sleepiness
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary outcomes:
measure: Evaluations of fatigue.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of cognition.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
measure: Evaluation of depression.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
measure: Evaluation of quality of life.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of inflammation.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of blood pressure.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of sexual dysfunction.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of anxiety
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of metabolism
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
measure: Evaluation of hormonal alterations.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
measure: Evaluation of heart rate variability
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
measure: Evaluation of endothelial disfunction.
timeFrame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Associação Fundo de Incentivo à Pesquisa
state: SP
Study officials:
References:
citation: 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.
citation: 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.