Obstructive Sleep ApneaNCT04962165
Obstructive Sleep Apnea Management in People With Spinal Cord Injury
A study testing Mandibular Advancement Device in people with Obstructive Sleep Apnea and Spinal Cord Injuries, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Spinal Cord Injuries
- What is being tested?
- Mandibular Advancement Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2021to 30 Nov 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 5 on polygraphy
- sufficient set of teeth to hold a splint
- written informed consent
Who cannot join
- use of medication that could affect breathing or sleep
- oxygen-dependent or decompensated lung disease
- decompensated congestive heart failure
- evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia)
- abnormalities of the upper airway
- periodontal problems and untreated caries
- mental disorders
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Paraple Center - rehab center for SCI people
Prague, 150 06
David Lukes, MSc, +420274771478, lukes@paraple.cz
About this study
Official title: Obstructive Sleep Apnea Management in People With Spinal Cord Injury, Treatment Options by Mandibular Advancement Device
The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. The purpose of this study is to determine the efficacy of MAD in people with SCI and to verify their adherence to the therapy.
Read the detailed description
Obstructive sleep apnea (OSA) is a disorder with serious health consequences. Compared to the general population, a significantly higher prevalence of OSA was found in individuals with spinal cord injury (SCI). As treatment, positive pressure therapy in the respiratory tract during sleep (CPAP) is commonly instituted. However, CPAP therapy is often rejected or poorly tolerated by patients. Alternatively, the American Association of Sleep Medicine recommends the use of Mandibular Advancement Devices (MAD). The MAD prevents the upper airway from collapsing by anterior displacement of the mandible.
The aim of the project is to determine the efficacy of MAD therapy in people with SCI and to verify their adherence to the therapy. The research group will consist of 60-80 subjects. The selection of suitable participants will be based on the results of a polygram. The MAD for a group of subjects with an apnea-hypopnea index (AHI) higher than five will be fabricated using their dental impressions. Subsequently, the subjects will be retested while wearing the MAD and outcomes will be compared. The evaluation will include a set of questionnaires. Adherence to therapy will be checked after three and six months.
The investigators anticipate that the results of the study will confirm the effectiveness of MAD devices in the treatment of OSA in the monitored group. Most importantly, the investigators intend to set a standard for a long-term system of diagnosing and addressing OSA in individuals with SCI.
- Conditions
- Obstructive Sleep Apnea, Spinal Cord Injuries
- Being tested
- Mandibular Advancement Device
- Keywords
- Apnea, Spinal cord injury, Mandibular Advancement Device
- Medical subject headings
- Sleep Apnea, Obstructive, Spinal Cord Injuries, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DeviceDevice
The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea. Receives: Device: Mandibular Advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea index (AHI)
The obstructive Apnea-Hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polygraphy.
Measured: through study completion, an average of 6 month
Secondary outcomes (2)
Daytime sleepiness
The Epworth sleepiness scale (ESS) will measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations. The minimum scale values of 0-7 indicate no likeliness of being abnormally sleepy, the maximum scale values of 16-24 indicate excessive sleepiness.
Measured: through study completion, an average of 6 month
Quality of life measurement
The WHOQOL-BREF will be used to measure the quality of life. This instrument is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Scores range from 0 to 100 with 100 indicating a higher quality of life.
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Jiri Kriz, MD, PhD, University Hospital, Motol
- Investigators
- Jiri Kriz, MD, PhD, Study director, Spinal Cord Unit, University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962165
- Sponsor's protocol ID
- SCI_APNEA_2021
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.
PubMed 31717429Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.
PubMed 29735608Kriz J., Kyselova A., Sever D. Sleep Apnea In Patients With Chronic Spinal Cord Injury. Abstractbook. The 4th ISCoS and ASIA Joint Scientific Meeting, May 14-16, 2015, Montreal, Canada.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Management in People With Spinal Cord Injury, Treatment Options by Mandibular Advancement Device
- ClinicalTrials.gov ID
- NCT04962165
- Acronym / sponsor ID
- SCI_APNEA_2021
- Conditions
- Obstructive Sleep Apnea, Spinal Cord Injuries
- Keywords
- Apnea, Spinal cord injury, Mandibular Advancement Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 14 Jul 2021 (actual)
- 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.
The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. The purpose of this study is to determine the efficacy of MAD in people with SCI and to verify their adherence to the therapy.
Detailed description
Obstructive sleep apnea (OSA) is a disorder with serious health consequences. Compared to the general population, a significantly higher prevalence of OSA was found in individuals with spinal cord injury (SCI). As treatment, positive pressure therapy in the respiratory tract during sleep (CPAP) is commonly instituted. However, CPAP therapy is often rejected or poorly tolerated by patients. Alternatively, the American Association of Sleep Medicine recommends the use of Mandibular Advancement Devices (MAD). The MAD prevents the upper airway from collapsing by anterior displacement of the mandible.
The aim of the project is to determine the efficacy of MAD therapy in people with SCI and to verify their adherence to the therapy. The research group will consist of 60-80 subjects. The selection of suitable participants will be based on the results of a polygram. The MAD for a group of subjects with an apnea-hypopnea index (AHI) higher than five will be fabricated using their dental impressions. Subsequently, the subjects will be retested while wearing the MAD and outcomes will be compared. The evaluation will include a set of questionnaires. Adherence to therapy will be checked after three and six months.
The investigators anticipate that the results of the study will confirm the effectiveness of MAD devices in the treatment of OSA in the monitored group. Most importantly, the investigators intend to set a standard for a long-term system of diagnosing and addressing OSA in individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Mandibular Advancement DeviceThe group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI > 5 on polygraphy
- sufficient set of teeth to hold a splint
- written informed consent
Key exclusion criteria (7 listed)
- use of medication that could affect breathing or sleep
- oxygen-dependent or decompensated lung disease
- decompensated congestive heart failure
- evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia)
- abnormalities of the upper airway
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 |
|---|---|---|
| Mandibular Advancement DeviceThe device maintain opened upper airway by moving the lower jaw slightly forward while sleeping. | Device | Experimental group |
Primary outcome
Apnea-Hypopnea index (AHI)
Time frame: through study completion, an average of 6 month
The obstructive Apnea-Hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polygraphy.
2 secondary outcomes
Daytime sleepiness
Time frame: through study completion, an average of 6 month
Quality of life measurement
Time frame: through study completion, an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 31717429Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.
- Background: PubMed 29735608Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.
- BackgroundKriz J., Kyselova A., Sever D. Sleep Apnea In Patients With Chronic Spinal Cord Injury. Abstractbook. The 4th ISCoS and ASIA Joint Scientific Meeting, May 14-16, 2015, Montreal, Canada.
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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.
Jiri Kriz, MD, PhD study director
Spinal Cord Unit, University Hospital Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Advancement Device in people with Obstructive Sleep Apnea and Spinal Cord Injuries, run by University Hospital, Motol at 1 site in Czechia.
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 3 inclusion and 7 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Contact Lenka Honzatkova, MSc (+420274771478, honzatkova@paraple.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea index (AHI) (time frame: through study completion, an average of 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962165, which also lists 3 linked publications.
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 14 Mar 2023.