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

University of Tromso (UiT)

Status: Unknown

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Mandibular Advancing Splint; Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02953028

OSAstudie-UiT

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Continuous Positive Airway Pressure

Active Comparator group

Description:

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.

Treatment:

Device: CPAP

Mandibular Advancing Splint

Active Comparator group

Description:

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.

Treatment:

Device: Mandibular Advancing Splint