NCT01336556

Brief Summary

Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances. Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea. Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index \< 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

April 14, 2011

Last Update Submit

October 25, 2011

Conditions

Obstructive Sleep Apnea

Keywords

Oral applianceContinuous positive airway pressureObstructive Sleep Apnea SyndromeSnore

Outcome Measures

Primary Outcomes (1)

  • Objective sleep parameters

    polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation

    two months after the baseline recording

Secondary Outcomes (2)

  • Subjective sleep parameters

    two months after the baseline recording

  • Quality of life, mood, and anthropometric measurements

    two months after the baseline recording

Interventions

Oral appliancePROCEDURE

Anterior mandibular repositioner: used for two months

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects aged between 25 and 65 years old
  • Epworth sleepiness Scale \> 9
  • Apnea-hypopnea index between 5 and 30

You may not qualify if:

  • Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
  • Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
  • Loss of posterior dental support to undermine the retention of oral appliance
  • Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
  • Protrusive displacement lass then five millimeters
  • Limited mouth opening
  • Alcoholism
  • Use of sleep-inducing medications
  • Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
  • Intolerance to CPAP
  • Obesity grade II (moderate) or III (severe)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSnoring

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lia Rita A Bittencourt, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thays CA Cunha

CONTACT

551121490155thayscrosara@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 18, 2011

Study Start

October 1, 2010

Primary Completion

November 1, 2011

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

BR(1)