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Obstructive Sleep Apnea Management in People With Spinal Cord Injury

Primary Purpose

Obstructive Sleep Apnea, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Mandibular Advancement Device
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Apnea, Spinal cord injury, Mandibular Advancement Device

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paraple Center - rehab center for SCI peopleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 7, 2021
Last Updated
March 12, 2023
Sponsor
University Hospital, Motol
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1. Study Identification

Unique Protocol Identification Number
NCT04962165
Brief Title
Obstructive Sleep Apnea Management in People With Spinal Cord Injury
Official Title
Obstructive Sleep Apnea Management in People With Spinal Cord Injury, Treatment Options by Mandibular Advancement Device
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Spinal Cord Injuries
Keywords
Apnea, Spinal cord injury, Mandibular Advancement Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The group of SCI people will use a mandibular advancement device for treatment of obstructive sleep apnea.
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Device
Intervention Description
The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea index (AHI)
Description
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.
Time Frame
through study completion, an average of 6 month
Secondary Outcome Measure Information:
Title
Daytime sleepiness
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Quality of life measurement
Description
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.
Time Frame
through study completion, an average of 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lenka Honzatkova, MSc
Phone
+420274771478
Email
honzatkova@paraple.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Kriz, MD, PhD
Organizational Affiliation
Spinal Cord Unit, University Hospital Motol
Official's Role
Study Director
Facility Information:
Facility Name
Paraple Center - rehab center for SCI people
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lukes, MSc
Phone
+420274771478
Email
lukes@paraple.cz

12. IPD Sharing Statement

Citations:
PubMed Identifier
31717429
Citation
Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.
Results Reference
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PubMed Identifier
29735608
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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Obstructive Sleep Apnea Management in People With Spinal Cord Injury

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