Clinical trial NCT02953028: Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: Public Dental Service Competence Centre of Northern Norway
name: St. Olavs Hospital
First posted: 2016-11-02
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Association between patient characteristics and adherence to treatment With either CPAP or MAS
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
timeFrame: 4 months
measure: Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
timeFrame: 12 months
measure: Self-reported patient compliance to MAS or CPAP collected by questionnaire
timeFrame: 4 months
measure: Self-reported patient compliance to MAS or CPAP collected by questionnaire
timeFrame: 12 months
measure: Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
timeFrame: 4 months
measure: Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
timeFrame: 12 months
measure: Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 months
measure: Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 months
measure: Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
state: Sør-Trøndelag
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University of Tromsø, Department of Community Medicine
name: Tordis A. Trovik, PhD, DDS
role: STUDY_CHAIR
References: