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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02953028
• Other study ID #: OSAstudie-UiT
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: December 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure
• Mandibular Advancing Splint
Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms
Norway	St.Olavs Hospital	Trondheim	Sør-Trøndelag

Sponsors (4)

Lead Sponsor	Collaborator
University of Tromso	Public Dental Service Competence Centre of Northern Norway, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.	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
Secondary	Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.	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
Secondary	Self-reported patient compliance to MAS or CPAP collected by questionnaire	Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA	4 months
Secondary	Self-reported patient compliance to MAS or CPAP collected by questionnaire	Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA	12 months
Secondary	Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)	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
Secondary	Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)	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
Secondary	Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)	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
Secondary	Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)	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