Sleep Apnea, ObstructiveNCT02953028
Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance
A study testing CPAP and Mandibular Advancing Splint in people with Sleep Apnea, Obstructive, run by University of Tromso at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP and Mandibular Advancing Splint
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2014to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
2 sites in 1 country.
Norway2 sites
University Hospital of North Norway
Tromsø, Troms, N-9038
St.Olavs Hospital
Trondheim, Sør-Trøndelag, N-7006
About this study
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
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
- Being tested
- CPAP, Mandibular Advancing Splint
- 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
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Resmed Autoset S9
Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure
Mandibular Advancing SplintDevice
Also called Respire Blue, Somnodent Fusion
Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | 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. Receives: Device: CPAP |
| Mandibular Advancing Splint | Active comparator | 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. Receives: Device: Mandibular Advancing Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 4 months
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.
Measured: 12 months
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
Measured: 4 months
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
Measured: 12 months
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
Measured: 4 months
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
Measured: 12 months
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
Measured: 4 months
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
Measured: 12 months
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
Measured: 4 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2014
- Primary completionAug 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Public Dental Service Competence Centre of Northern Norway, St. Olavs Hospital
- Responsible party
- Principal investigator, Lars Martin Berg, University of Tromso
- Investigators
- Tordis A. Trovik, PhD, DDS, Study chair, University of Tromsø, Department of Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953028
- Sponsor's protocol ID
- OSAstudie-UiT
- Status last verified
- Apr 2019
- First submitted
- 26 Feb 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02953028
- Acronym / sponsor ID
- OSAstudie-UiT
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Public Dental Service Competence Centre of Northern Norway, St. Olavs Hospital
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Device: CPAPPatients 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. |
| Mandibular Advancing Splint | Active comparator | Device: Mandibular Advancing SplintPatients 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Primarily central sleep apnea
- Known temporomandibular dysfunction (TMD)
- Mental instability
- Drug abuse
- Extensive usage of sedative medication which disqualifies for OSA-treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Resmed Autoset S9Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure | Device | Continuous Positive Airway Pressure |
| Mandibular Advancing SplintAlso: Respire Blue, Somnodent FusionOral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea | Device | Mandibular Advancing Splint |
Primary outcome
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.
10 secondary outcomes
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time frame: 4 months
Efficacy of MAS and CPAP measured by Apnea-Hypopnea-Index (AHI). Data collected by respiratory polygraphy.
Time frame: 12 months
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time frame: 4 months
Self-reported patient compliance to MAS or CPAP collected by questionnaire
Time frame: 12 months
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time frame: 4 months
Self-reported quality of life collected by the questionnaire Short Form-36 (SF-36)
Time frame: 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 symptoms of anxiety and/or depression through the questionnaire Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 months
Self-reported experience of sleep-quality through the questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tordis A. Trovik, PhD, DDS study chair
University of Tromsø, Department of Community Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and Mandibular Advancing Splint in people with Sleep Apnea, Obstructive, run by University of Tromso at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between patient characteristics and adherence to treatment With either CPAP or MAS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.