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Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

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ClinicalTrials.gov Identifier: NCT02907398
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.

Study Description
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Brief Summary:

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: Inspire therapy Other: No intervention

Detailed Description:
This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Actual Study Start Date : October 19, 2016
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ADHERE
This group will include 250 patients who have been implanted with the Inspire therapy system, enrolled in the ADHERE Registry, and are willing to complete a follow-up home sleep apnea test (HSAT).
 Device: Inspire therapy
Other Name: ADHERE
CONTROL
This group will include 100 patients who have been denied insurance coverage of the Inspire therapy system implant by their provider, have had no intervention (Inspire), and are willing to complete a HSAT and provide information about their OSA treatment after denial.
 Other: No intervention
Other Name: CONTROL


Outcome Measures
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Primary Outcome Measures :
  1. Change in Apnea Hypopnea (AHI) from Baseline to 12-Months [ Time Frame: Baseline through 12 months ]
    Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI will be determined by the AHI score at the post-titration visit compared with the pre-implant baseline score.

  2. Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months [ Time Frame: Baseline through 12 months ]
    The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. ESS scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline.


Secondary Outcome Measures :
  1. Patient Experience with Therapy (PET) [ Time Frame: Through 12 months ]
    The PET is a survey deigned to collect information about patients' experience with the Inspire therapy. Information will be collected once the therapy is activated about relative satisfaction with the therapy over time.

  2. Therapy Adherence [ Time Frame: Through 12 months ]
    Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic. This value can be used to quantify device use and adherence over time.

  3. Advance or Additional Titrations [ Time Frame: Through 12 months ]
    The patient will report the number of in-office or sleep lab device titrations completed.

  4. Physical Assessment [ Time Frame: Baseline through 12 months ]
    Blood pressure, and height (in either cm or in) & weight (in either kg or lbs) will be used to calculate Body Mass Index at baseline and through study completion.

  5. Clinical Global Impression (CGI-I) [ Time Frame: Baseline through 12 months ]
    The Clinical Global Impression (CGI-I) is a clinician assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. During the assessment the physician rates the patient's obstructive sleep apnea by selecting 1 of 7 categories that range from very much worse to very much improved (in comparison to baseline).

  6. Device Data Collection [ Time Frame: Through 12 months ]
    Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.

  7. Insomnia Severity Index (ISI) [ Time Frame: Baseline through 12 months ]
    The Insomnia Severity Index (ISI) is a 7 item self-report instrument that measures patient perception of both nocturnal and diurnal symptoms of insomnia. Scores range from 0 to 28, with a lower score indicating less severe insomnia.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for an Inspire implant or who had an Inspire implant prior to the initiation of the Registry. In addition, those patients who were denied insurance coverage for the implant.
Criteria

Inclusion Criteria:

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

  1. Capable of giving informed consent, as required per institution
  2. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria:

Any patient who meets any of the following criteria will not be eligible to participate in the registry

  1. Has a life expectancy of less than 1 year
  2. Any reason the clinician deems patient is unfit for participation in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907398


Contacts
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Contact: Anna Bader (763) 290-1174 annabader@inspiresleep.com
Contact: Justin Peterson justinpeterson@inspiresleep.com

Locations
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Sponsors and Collaborators
Inspire Medical Systems, Inc.
Investigators
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Study Director: Gwen Gimmestad Inspire Medical Systems, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02907398    
Other Study ID Numbers: ADHERE UAS Registry
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Inspire Medical Systems, Inc.:
Neurostimulation
Hypoglossal nerve
Tongue
Upper airway stimulation
Surgery
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases