Cervical Stabilization in Individuals With Obstructive Sleep Apnea

NCT ID: NCT03154970

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2017-08-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

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

Study Groups

Obstructive sleep apnea group (G OSA)

The cervical stabilization will be performed with craniocervical flexion training aiming to strength the deep cervical flexors. For this purpose a pressure biofeedback device (stabilizer) that allows progressive levels of pressure during exercise(22-30 mmHg) will be used, which will be increased according to the capacity of the individuals (avoiding compensations or pain). The participant will be instructed to perform the craniocervical flexion in the supine position, the duration of the contraction will be 10 seconds followed by 10 seconds of rest (3 sets of 10 repetitions). The sessions will be held 2 times in weeks, for 6 weeks.

Group Type: EXPERIMENTAL

Craniocervical flexion training

Intervention Type: DEVICE

The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks

Control group (GC)

The GC will be reassessed after six weeks and the same G OSA treatment will be offered after this period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Craniocervical flexion training

The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Eliane Correa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

UFSM-AOS-01

Identifier Type: -

Identifier Source: org_study_id