- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953028
Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance
April 30, 2019 updated by: Lars Martin Berg, University of Tromso
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sør-Trøndelag
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Trondheim, Sør-Trøndelag, Norway, N-7006
- St.Olavs Hospital
-
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Troms
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Tromsø, Troms, Norway, N-9038
- University Hospital of North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure
Other Names:
|
Active Comparator: 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.
|
Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between patient characteristics and adherence to treatment With either CPAP or MAS
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time Frame: 4 months
|
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.
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4 months
|
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time Frame: 12 months
|
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
|
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time Frame: 4 months
|
Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA
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4 months
|
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time Frame: 12 months
|
Patient adherence to the use of MAS or CPAP in patients having mild or moderate OSA
|
12 months
|
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time Frame: 4 months
|
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
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4 months
|
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time Frame: 12 months
|
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
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12 months
|
Self-reported symptoms of anxiety and/or depression collected by the questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 months
|
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
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4 months
|
Self-reported symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 months
|
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
|
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 months
|
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
|
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Tordis A. Trovik, PhD, DDS, University of Tromsø, Department of Community Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
February 26, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (Estimate)
November 2, 2016
Study Record Updates
Last Update Posted (Actual)
May 2, 2019
Last Update Submitted That Met QC Criteria
April 30, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSAstudie-UiT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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