Clinical trial NCT03154970: Cervical Stabilization in Individuals With Obstructive Sleep Apnea
Official title: Cervical Stabilization in Individuals With Obstructive Sleep Apnea: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Physical Therapy Specialty
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be performed in people with obstructive sleep apnea, in which one group will receive treatment with cervical stabilization for six weeks and the control group will receive treatment after the interval of six weeks

Detailed description: The objective of this study was to evaluate the muscle strength of the cervical flexor and extensor muscles, to investigate the presence of cervical dysfunction and temporomandibular dysfunction, as well as to verify the effects of cervical stabilization in individuals with obstructive sleep apnea (OSA). The research will be carried out at the Orofacial Motricity Laboratory of the Federal University of Santa Maria (UFSM) and the University Hospital of Santa Maria (HUSM). Men and women between 20 and 60 years of age with a diagnosis of OSA will be invited to participate in this study, confirmed by polysomnography. The sample will consist of 22 patients with OSA, 11 subjects in the OSA group (OSA G) and 11 in the control group (CG) randomly. At the initial evaluation, an anamnesis will be performed and participants will respond to the Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI) and STOP-Bang questionnaire. The craniocervical posture will also be evaluated through photogrammetry (SAPo); The presence and severity of temporomandibular dysfunction (TMD) by the instruments Diagnostic Criteria in Research for Temporomandibular Dysfunction (RDC / TMD) and Temporomandibular Index (TMT); The presence of cervical dysfunction by the Craniocervical Dysfunction Index (CCID); The pressure pain threshold and the strength of the cervical flexor and extensor muscles, by pressure algometry and dynamometry, respectively. The OSA G will be submitted to cervical stabilization using the pressure biofeedback device (Stabilizer) and, after six weeks will be reassessed by the same questionnaires and instruments of the initial evaluation. The CG after six weeks will be reevaluated and the same treatment protocol will be offered.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 20 to 60 years;
* Clinical diagnosis of obstructive apnea of mild, moderate or severe sleep through polysomnography following the apnea / hypopnea index.

Exclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 35 kg / m2;
* Use of continuous positive airway pressure;
* Diagnosis of neurological or neuromuscular disease;
* History of craniocervical trauma;
* Be under physiotherapeutic or speech-language therapy for, respectively, craniocervical and orofacial motor dysfunction or have performed in the last three months;
* Being in use of intraoral orthodontic appliances, which produce mandibular advancement

Primary outcomes:
measure: Change of sleep quality
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Change of craniocervical dysfunction index
timeFrame: Baseline and 7 weeks
measure: Change of pressure pain threshold
timeFrame: Baseline and 7 weeks
measure: Change of presence and and severity of temporomandibular dysfunction (TMD)
timeFrame: Baseline and 7 weeks
measure: Change of cervical posture
timeFrame: Baseline and 7 weeks
measure: Change of muscle strength
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: Rio Grande Do Sul
Study officials:
References: