Obstructive Sleep Apnea Management in People With Spinal Cord Injury

NCT ID: NCT04962165

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-11-30

Brief 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. 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.

Conditions

Obstructive Sleep Apnea; Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea.

Group Type: EXPERIMENTAL

Mandibular Advancement Device

Intervention Type: DEVICE

The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.

Interventions

Mandibular Advancement Device

The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• AHI > 5 on polygraphy
• sufficient set of teeth to hold a splint
• written informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. Jiri Kriz, MD, PhD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiri Kriz, MD, PhD

Role: STUDY_DIRECTOR

Spinal Cord Unit, University Hospital Motol

Locations

Paraple Center - rehab center for SCI people

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Lenka Honzatkova, MSc

Role: CONTACT

honzatkova@paraple.cz

+420274771478

Facility Contacts

David Lukes, MSc

Role: primary

lukes@paraple.cz

+420274771478

References

Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.

Reference Type: BACKGROUND

PMID: 31717429 (View on PubMed)

Graco 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.

Reference Type: BACKGROUND

PMID: 29735608 (View on PubMed)

Kriz 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.

Reference Type: BACKGROUND

Other Identifiers

SCI_APNEA_2021

Identifier Type: -

Identifier Source: org_study_id