NCT03154970

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 7, 2017

Last Update Submit

May 1, 2018

Conditions

Obstructive Sleep Apnea

Keywords

Physical Therapy Specialty

Outcome Measures

Primary Outcomes (1)

  • Change of sleep quality

    Sleep quality will be assessed twice through the Pittsburgh sleep quality index (PSQI), composed of nine self-administered questions, with scores scattered on a scale of zero to three. The sum of the responses provided by the overall score, which ranges from zero to 21, where the higher the score, the worse the quality of sleep.

    Baseline and 7 weeks

Secondary Outcomes (5)

  • Change of craniocervical dysfunction index

    Baseline and 7 weeks

  • Change of pressure pain threshold

    Baseline and 7 weeks

  • Change of presence and and severity of temporomandibular dysfunction (TMD)

    Baseline and 7 weeks

  • Change of cervical posture

    Baseline and 7 weeks

  • Change of muscle strength

    Baseline and 7 weeks

Study Arms (2)

Obstructive sleep apnea group (G OSA)

EXPERIMENTAL

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.

Device: Craniocervical flexion training

Control group (GC)

NO INTERVENTION

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

Interventions

Craniocervical flexion trainingDEVICE

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

Obstructive sleep apnea group (G OSA)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 16, 2017

Study Start

May 22, 2017

Primary Completion

July 30, 2017

Study Completion

August 30, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

BR(1)