Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance

April 30, 2019 updated by: Lars Martin Berg, University of Tromso

Treatment of Mild and Moderate Obstructive Sleep Apnea (OSA) by Continuous Positive Airway Pressure (CPAP) or Mandibular Advancing Splint (MAS) - a Randomized Controlled Trial on Patient Specific Factors, Success Rate and Compliance

Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased risk for developing cardiovascular disease and increased risk of accidents caused by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is effective and must be used for life. However, CPAP-treatment might be uncomfortable for the patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints (MAS), which is perceived as less troublesome and may initiate higher compliance. Through mapping of patient characteristics, the researchers investigate which patient-type benefits most from two different treatment-devices. The aim of the study is to assess how the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on health related quality of life among patient diagnosed with mild/moderate OSA. All OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital, Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The sample size at completion of the study should be 140 patients. Participants in the trial were randomly allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected through anamnesis, clinical examination, clinical photos, radiographs and questionnaires concerning general health related quality of life (SF36), oral health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sør-Trøndelag
      • Trondheim, Sør-Trøndelag, Norway, N-7006
        • St.Olavs Hospital
    • Troms
      • Tromsø, Troms, Norway, N-9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10 ≤ Apnea-Hypopnea-Index ≤ 30 at baseline
  • Subjective symptoms of OSA
  • Ability of at least 5mm protrusion of the mandible
  • Accept randomization of treatment modality
  • Accept to fill in the questionnaires
  • Accept to attend at planned consultations

Exclusion Criteria:

  • Primarily central sleep apnea
  • Known temporomandibular dysfunction (TMD)
  • Mental instability
  • Drug abuse
  • Extensive usage of sedative medication which disqualifies for OSA-treatment
  • Extensive gag-reflex or claustrophobia
  • Inadequate dental support (< 10 teeth in lower jaw)
  • Inadequate periodontal support (no tooth mobility > Miller grade I)
  • Anatomical abnormalities in the nasal cavity or oro-pharynx that disqualifies the use of CPAP and/or MAS
  • Anatomical abnormalities which should be surgically corrected before treatment with CPAP and/or MAS
  • Severely compromised general health condition
  • Pregnancy
  • General health issues that disqualifies the use of CPAP and or MAS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Positive Airway Pressure
Patients treated With an auto-CPAP-machine which is a compressor Connected to a nose- or face mask which provides increased air pressure, opening the upper Airways during an apnea or hypopnea event.
Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure
Other Names:
  • Resmed Autoset S9
Active Comparator: Mandibular Advancing Splint
Patients treated With a twin block splint (oral appliance) advancing the mandible and thereby opening the upper Airways for easier passage of air during sleep preventing apnea and hypopnea events.
Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea
Other Names:
  • Respire Blue
  • Somnodent Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between patient characteristics and adherence to treatment With either CPAP or MAS
Time Frame: 12 months
Combining measurements from questionnaires at baseline and 12 months to map the patient characteristics of those patients treated for mild or moderate OSA who comply, or do not comply to CPAP-intervention or MAS-intervention respectively. Detailed description of measurements collected are listed in secondary outcome measures.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time Frame: 4 months
Objective measurement of the efficacy of MAS or CPAP treatment in patients having mild or moderate OSA. Apnea-events/hypopnea-events and oxygen desaturation-index registered by respiratory polygraphy are combined to give an AHI-score before treatment and after 4 months of intervention.
4 months
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time Frame: 12 months
Objective measurement of the efficacy of MAS or CPAP treatment in patients having mild or moderate OSA. Apnea-events/hypopnea-events and oxygen desaturation-index registered by respiratory polygraphy are combined to give an AHI-score before treatment and after 12 months of intervention.
12 months
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time Frame: 4 months
Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA
4 months
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time Frame: 12 months
Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA
12 months
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time Frame: 4 months
Health related Quality of life at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
4 months
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time Frame: 12 months
Health related Quality of life at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
12 months
Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 months
Self reported signs on depression and anxiety at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
4 months
Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 months
Self reported signs on depression and anxiety at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
12 months
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 months
Self perceived sleep quality at baseline and after 4 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
4 months
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 months
Self perceived sleep quality at baseline and after 12 months of treatment with either MAS or CPAP in patients having mild or moderate OSA
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Tordis A. Trovik, PhD, DDS, University of Tromsø, Department of Community Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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