OSANOURMT-OSANCT03664765
Novel by Upper Airway Respiratory Muscle Training to Treat OSA in Chronic SCI
A study testing UA and RMT in people with OSA and SCI/D, run by VA Office of Research and Development at 1 site in United States.
Trial summary
It is estimated that spinal cord injury (SCI) affects approximately 12,000 new individuals every year in the United States, with the majority are cervical and/or upper thoracic injuries. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- OSA, SCI/D, Upper Airway Exercise
- What is being tested?
- UA and RMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with chronic SCI/D (>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of OSA
- excluding those with no evidence of a neurologic deficit based on ASIA classification
- Specifically, the study will target those with SCI/D and OSA who would like alternative treatment options or to have a lower PAP pressure, if they refused, or did not tolerate PAP treatment
Who cannot join
- Receiving continuous mechanical ventilation
- except PAP therapy which is considered usual treatment for SDB)
- Severe congestive heart failure with ejection fraction <35%
- Recent health event that may affect sleep
- stroke
- acute myocardial infarction
Show all 12Show fewer
- recent surgery
- hospitalization
- Alcohol or substance abuse (<90 days sobriety)
- Self-described as too ill to engage in study procedures
- Unable to provide self-consent for participation
- Central sleep apnea (CSA) defined as central apnea/hypopnea index >50% of the AHI
Trial locations and contacts
1 site in 1 country.
United States1 site
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
About this study
Official title: Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training
It is estimated that spinal cord injury (SCI) affects approximately 12,000 new individuals every year in the United States, with the majority are cervical and/or upper thoracic injuries. Despite this high prevalence of obstructive sleep apnea (OSA) in chronic SCI population minority of patients are treated and are adherent to standard therapy (CPAP). This proposal addresses a new therapeutic intervention for OSA in SCI. The investigators hypothesized that combined oropharyngeal and respiratory muscle exercises improve respiratory symptoms and alleviate OSA in patients with chronic SCI. The investigators will perform a pilot randomized, sham-controlled study to examine the impact of combined daily exercises (~30 min) for 1 and 3 months durations among Veterans with SCI. The investigators believe that this novel approach to treating OSA and will yield significant new knowledge that improves the health and quality of life of these patients.
Read the detailed description
In recent years, the investigators and others have discovered that spinal cord injury/disease (SCI/D) is associated with significant increase in the sleep-disordered breathing (SDB) prevalence. Nearly 80% of patients with SCI/D including Veterans suffer from SDB after six months of injury (majority of them 70-80% are obstructive apneas and hypopneas-OSA). However, most patients SCI/D do not tolerate standard SDB treatment (continuous positive airway pressure-CPAP) leading to lack of compliance. Therefore, identifying other therapies is important for this common condition that is linked to poor outcome in the general population (heart disease, stroke, hypertension and poor cognition). It has been reported in sleep apnea able-bodied patients that oropharyngeal muscle exercises for 3 months using speech pathology techniques improve the severity of SDB. Furthermore, previous studies showed respiratory muscle training (RMT) is effective for increasing respiratory muscle strength in people with cervical SCI. However, the effect of combined oropharyngeal and RMT on OSA in patients with SCI is unknown.
The purpose of this application is to identify new therapeutic interventions for OSA treatment in Veterans with SCI/D. This application proposes for a pilot study to randomizing 30 Veterans with SCI/D and OSA to receive 3 months of daily (30 minutes) treatment with a validated set of oropharyngeal and RMT (intervention arm) versus sham therapy (control arm). There will be three specific aims to address the following hypotheses:
Specific Aim (1): To test recruitment rate and feasibility of a pilot intervention that includes combined oropharyngeal and RMT versus sham treatment in individuals with SCI/D.
Specific Aim (2): To test the acceptability and usability of combined oropharyngeal and RMT in individuals with SCI/D.
Specific Aim (3): To determine the effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial.
- Conditions
- OSA, SCI/D, Upper Airway Exercise
- Being tested
- UA and RMT, Sham exercise
- Keywords
- OSA, SCI/D, RMT, Upper airway exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UA and RMTOther
daily oropharyngeal and respiratory muscle exercises
Sham exerciseOther
Daily sham exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention exercise arm | Active comparator | daily oropharyngeal and respiratory muscle exercises Receives: Other: UA and RMT |
| Control arm | Sham comparator | Daily sham exercises Receives: Other: Sham exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-Number of Participants Who Complete the Three-month Protocol
Assess the feasibility of completing intervention arm (upper airway and respiratory muscle training arm) verses sham arm.
Measured: 3 months
Recruitment
Assess the recruitment rate of the study
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled pilot trial to assess the feasibility of using combined oropharyngeal and respiratory muscle training versus sham training on OSA in patients with chronic SCI/D
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Abdulghani Sankari, MD PhD, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664765
- Sponsor's protocol ID
- B2885-P
- Acronym
- NOURMT-OSA
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2018
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.
Publications
Sankari A, Najjar AA, Maresh SA, Prowting JL, Fung CH, Knack A, Yarandi H, Badr MS. Feasibility of oropharyngeal and respiratory muscle training in individuals with OSA and spinal cord injury or disease: A pilot study. Physiol Rep. 2024 Feb;12(3):e15930. doi: 10.14814/phy2.15930.
PubMed 38325913
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment of Sleep Apnea by Upper Airway and Respiratory Muscle Training
- ClinicalTrials.gov ID
- NCT03664765
- Acronym / sponsor ID
- NOURMT-OSA / B2885-P
- Conditions
- OSA, SCI/D, Upper Airway Exercise
- Keywords
- OSA, SCI/D, RMT, Upper airway exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is estimated that spinal cord injury (SCI) affects approximately 12,000 new individuals every year in the United States, with the majority are cervical and/or upper thoracic injuries. Despite this high prevalence of obstructive sleep apnea (OSA) in chronic SCI population minority of patients are treated and are adherent to standard therapy (CPAP). This proposal addresses a new therapeutic intervention for OSA in SCI. The investigators hypothesized that combined oropharyngeal and respiratory muscle exercises improve respiratory symptoms and alleviate OSA in patients with chronic SCI. The investigators will perform a pilot randomized, sham-controlled study to examine the impact of combined daily exercises (~30 min) for 1 and 3 months durations among Veterans with SCI. The investigators believe that this novel approach to treating OSA and will yield significant new knowledge that improves the health and quality of life of these patients.
Detailed description
In recent years, the investigators and others have discovered that spinal cord injury/disease (SCI/D) is associated with significant increase in the sleep-disordered breathing (SDB) prevalence. Nearly 80% of patients with SCI/D including Veterans suffer from SDB after six months of injury (majority of them 70-80% are obstructive apneas and hypopneas-OSA). However, most patients SCI/D do not tolerate standard SDB treatment (continuous positive airway pressure-CPAP) leading to lack of compliance. Therefore, identifying other therapies is important for this common condition that is linked to poor outcome in the general population (heart disease, stroke, hypertension and poor cognition). It has been reported in sleep apnea able-bodied patients that oropharyngeal muscle exercises for 3 months using speech pathology techniques improve the severity of SDB. Furthermore, previous studies showed respiratory muscle training (RMT) is effective for increasing respiratory muscle strength in people with cervical SCI. However, the effect of combined oropharyngeal and RMT on OSA in patients with SCI is unknown.
The purpose of this application is to identify new therapeutic interventions for OSA treatment in Veterans with SCI/D. This application proposes for a pilot study to randomizing 30 Veterans with SCI/D and OSA to receive 3 months of daily (30 minutes) treatment with a validated set of oropharyngeal and RMT (intervention arm) versus sham therapy (control arm). There will be three specific aims to address the following hypotheses:
Specific Aim (1): To test recruitment rate and feasibility of a pilot intervention that includes combined oropharyngeal and RMT versus sham treatment in individuals with SCI/D.
Specific Aim (2): To test the acceptability and usability of combined oropharyngeal and RMT in individuals with SCI/D.
Specific Aim (3): To determine the effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled pilot trial to assess the feasibility of using combined oropharyngeal and respiratory muscle training versus sham training on OSA in patients with chronic SCI/D
| Arm | Type | Receives |
|---|---|---|
| Intervention exercise arm | Active comparator | Other: UA and RMTdaily oropharyngeal and respiratory muscle exercises |
| Control arm | Sham comparator | Other: Sham exerciseDaily sham exercises |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with chronic SCI/D (>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of OSA
- Specifically, the study will target those with SCI/D and OSA who would like alternative treatment options or to have a lower PAP pressure, if they refused, or did not tolerate PAP treatment
Key exclusion criteria (12 listed)
- Receiving continuous mechanical ventilation
- Severe congestive heart failure with ejection fraction <35%
- Recent health event that may affect sleep
- Alcohol or substance abuse (<90 days sobriety)
- Self-described as too ill to engage in study procedures
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 |
|---|---|---|
| UA and RMTdaily oropharyngeal and respiratory muscle exercises | Other | Intervention exercise arm |
| Sham exerciseDaily sham exercises | Other | Control arm |
Primary outcome
Feasibility-Number of Participants Who Complete the Three-month Protocol
Time frame: 3 months
Assess the feasibility of completing intervention arm (upper airway and respiratory muscle training arm) verses sham arm.
Recruitment
Time frame: 3 years
Assess the recruitment rate of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38325913Sankari A, Najjar AA, Maresh SA, Prowting JL, Fung CH, Knack A, Yarandi H, Badr MS. Feasibility of oropharyngeal and respiratory muscle training in individuals with OSA and spinal cord injury or disease: A pilot study. Physiol Rep. 2024 Feb;12(3):e15930. doi: 10.14814/phy2.15930.
- Individual participant dataSharing planned: Yes. Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.
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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.
Abdulghani Sankari, MD PhD principal investigator
John D. Dingell VA Medical Center, Detroit, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UA and RMT in people with OSA and SCI/D, run by VA Office of Research and Development at 1 site in United States.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 12 Mar 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility-Number of Participants Who Complete the Three-month Protocol (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03664765, which also lists 1 linked publication.
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 12 Mar 2024.