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

NCT02953028 | Unknown

• 1 other identifier: OSAstudie-UiT
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Continuous Positive Airway Pressure; Mandibular Advancing Splint; Efficacy; Compliance; Health related quality of life; Randomized Controlled Trial; Snoring; Mandibular Advancing Appliance; Mandibular Advancing Device; Humans; Quality of Life; Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Association between patient characteristics and adherence to treatment With either CPAP or MAS

  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 Outcomes (10)

• Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.

  4 months

• Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.

  12 months

• Self-reported patient compliance to MAS or CPAP collected by questionnaire

  4 months

• Self-reported patient compliance to MAS or CPAP collected by questionnaire

  12 months

• Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)

  4 months

Study Arms (2)

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

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.

Device: CPAP

Mandibular Advancing Splint

ACTIVE COMPARATOR

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.

Device: Mandibular Advancing Splint

Interventions

CPAP DEVICE

Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure

Also known as: Resmed Autoset S9

Continuous Positive Airway Pressure

Mandibular Advancing Splint DEVICE

Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea

Also known as: Respire Blue, Somnodent Fusion

Mandibular Advancing Splint

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator
• Public Dental Service Competence Centre of Northern Norway: collaborator
• St. Olavs Hospital: collaborator

Study Sites (2)

St.Olavs Hospital

Trondheim, Sør-Trøndelag, N-7006, Norway

Location

University Hospital of North Norway

Tromsø, Troms, N-9038, Norway

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Compliance; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tordis A. Trovik, PhD, DDS

  University of Tromsø, Department of Community Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)