Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02907398|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : July 16, 2020
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
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
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
- 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.
- 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.
- 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.
- 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.
- Advance or Additional Titrations [ Time Frame: Through 12 months ]The patient will report the number of in-office or sleep lab device titrations completed.
- 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.
- 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).
- 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.
- 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.
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
|Contact: Anna Bader||(763) firstname.lastname@example.org|
|Contact: Eric Collins||(763) email@example.com|
|Study Director:||Gwen Gimmestad||Inspire Medical Systems, Inc.|