Clinical trial NCT01636856: Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive
Official title: Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).
Keywords: oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.

Detailed description: This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.

Eligibility criteria: Inclusion Criteria:

subjects with primary snore, mild and moderate obstructive sleep apnea

Exclusion Criteria:

BMI \> or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.

Primary outcomes:
measure: Upper airway collapsability
timeFrame: 3 months
measure: Images from magnetic resonance
timeFrame: 3 months
measure: Negative expiratory pressure
timeFrame: 3 months
measure: Snore
timeFrame: 3 months
Secondary outcomes:
measure: Sleep related questionnaires
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Incor- Heart Institute, Sleep Laboratory
Study officials:
affiliation: Heart Institute - InCor
name: Vanessa Ieto
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute - InCor
name: Fabiane Kayamori
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute - InCor
name: Geraldo Lorenzi-Filho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ieto V, Kayamori F, Montes MI, Hirata RP, Gregorio MG, Alencar AM, Drager LF, Genta PR, Lorenzi-Filho G. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Chest. 2015 Sep;148(3):683-691. doi: 10.1378/chest.14-2953.