Pediatric Post-Approval Registry

Obstructive Sleep Apnea Clinical Trial

Official title:

Inspire Pediatric Post-Approval Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457154
• Other study ID #: 2020-002
• Status: Recruiting
• Start date: November 30, 2021
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: Inspire Medical Systems, Inc.
• Contact: Gwen Gimmestad
• Phone: 763-392-9966
• Email: gwengimmestad[@]inspiresleep.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Description:

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.

This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.

Study data will be collected at the following timepoints:

Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant

1, 2, 3, 4, 5 years post-implant

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Subject is between 18 and 21 years of age;

2. Subject has a diagnosis of moderate to severe OSA (15 = AHI = 65) based on a recent sleep study;

3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;

4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;

5. Subject has followed standard of care in considering all other alternative/adjunct therapies;

6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;

7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;

8. Subject is willing and able to provide informed consent.

Exclusion Criteria:

1. Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);

2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;

3. Subject has any condition or procedure that has compromised neurological control of the upper airway;

4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;

5. Subject is pregnant or plans to become pregnant;

6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;

7. Subject has a terminal illness with life expectancy < 12 months;

8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Inspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of Texas Southwestern/Children's Hospital of Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Children's Hospital of Philadelphia	King Of Prussia	Pennsylvania
United States	Children's Hospital of the King's Daughters/East Virginia Medical School	Norfolk	Virginia
United States	Children's Hospital of Pittsburgh	Sewickley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Inspire Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of device and/or procedure related adverse events over time	relevant adverse events will be collected and reported	Implant through 5 years post-implant
Primary	Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time	Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.	through 5 years post-implant
Secondary	Evaluation of improvement in Oxygen Desaturation Index (ODI) over time	Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.	through 5 years post-implant
Secondary	Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time	Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) < 90%. A lower T90 indicates less severe sleep apnea.	through 5 years post-implant
Secondary	Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time	Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. 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.	through 5 years post-implant