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

NCT ID: NCT02953028

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Mandibular Advancing Splint

Intervention Type: DEVICE

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

Interventions

CPAP

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

Intervention Type: DEVICE

Mandibular Advancing Splint

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

Intervention Type: DEVICE

Other Intervention Names

Resmed Autoset S9; Respire Blue; Somnodent Fusion

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Public Dental Service Competence Centre of Northern Norway

UNKNOWN

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Lars Martin Berg

PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tordis A. Trovik, PhD, DDS

Role: STUDY_CHAIR

University of Tromsø, Department of Community Medicine

Locations

St.Olavs Hospital

Trondheim, Sør-Trøndelag, Norway

University Hospital of North Norway

Tromsø, Troms, Norway

Countries

Norway

Other Identifiers

OSAstudie-UiT

Identifier Type: -

Identifier Source: org_study_id