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Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Primary Purpose

Down Syndrome, Obstructive Sleep Apnea

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Inspire Upper Airway Stimulation (UAS) System

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Hypoglossal nerve stimulation

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Down syndrome
Age 10-21 years
Prior adenotonsillectomy
Severe OSA (AHI > 10, AHI < 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment
Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment
Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device
Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion
Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation
Children and their parents/guardians must be proficient in English

Exclusion Criteria:

Body mass index (BMI) above the 95th percentile for subject's age
Circumferential airway collapse at the level of the velopharynx observed during DISE
Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration)
Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest
Patients with another implantable device which could interact unintentionally with the Inspire system
Any contraindication for general anesthesia
History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries
Subject is currently taking muscle relaxant medication
Life expectancy less than 12 months
Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment
Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling
Subjects with a co-occurring diagnosis of autism spectrum disorder
Subjects that have a positive β-HCG
Subjects deemed unfit for participation by the investigator for any other reason

Sites / Locations

Children's Healthcare of Atlanta/ Emory University School of MedicineRecruiting
Massachusetts General Hospital (Mass Eye & Ear Infirmary)Recruiting
Children's Hospital of PhiladelphiaRecruiting
Children's Hospital of PittsburghRecruiting
University of Texas Southwestern/Children's Hospital of DallasRecruiting
Children's Hospital of the King's Daughters/East Virginia Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects implanted with Inspire UAS System

Arm Description

Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.

Outcomes

Primary Outcome Measures

Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)

Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline

Change in attention using the Wechsler Intelligence Scale

Change in Cancellation scaled score of at least 0.5 standard deviation from baseline

Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline

Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)

Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline

Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning

Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline

Change in language using Expressive Language Sampling

Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline

Secondary Outcome Measures

Rate of procedure and device-related adverse events

Procedure and device-related adverse events will be collected in order to profile the safety of hypoglossal nerve stimulation in adolescents. Number and percent of procedure and device-related adverse events will be reported

Change in Obstructive Sleep Apnea (OSA)

Change in sleep apnea will be measured using standard in-lab PSG measures including oxygen level, partial and complete airway obstruction, and arousals. Improvement will be defined as a 50% or more decrease in AHI.

Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires

Quality of life improvements will be measured using the OSA-18 and ESS-CHAD. Mean scores for each questionnaire will be reported at baseline and 12 months post-implant.

Full Information

NCT ID

NCT04801771

First Posted

December 15, 2020

Last Updated

April 5, 2023

Sponsor

Inspire Medical Systems, Inc.

Collaborators

National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT04801771

Brief Title

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Official Title

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 24, 2021 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inspire Medical Systems, Inc.

Collaborators

National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System. Prior to implant subjects will be required to meet eligibility criteria, complete quality of life questionnaires and undergo neurocognitive testing (NCT) and expressive language sampling. Eligibility criteria will be determined via review of medical records, an in-lab polysomnography (sleep study), and a drug-induced sleep endoscopy (DISE). After implant of the Inspire UAS System, subjects will undergo five (5) study visits. Four (4) of the visits will include an in-lab sleep study (PSG). Follow-up expressive language sampling and neurocognitive testing will be performed at 6 months post-implant. Follow-up quality of life questionnaires will be completed at 12 months post-implant. Subjects will conclude their participation in the study at the end of their 12 month study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome, Obstructive Sleep Apnea

Keywords

Hypoglossal nerve stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects implanted with Inspire UAS System

Arm Type

Experimental

Arm Description

Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.

Intervention Type

Device

Intervention Name(s)

Inspire Upper Airway Stimulation (UAS) System

Other Intervention Name(s)

Hypoglossal nerve stimulation

Intervention Description

The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.

Primary Outcome Measure Information:

Title

Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)

Description

Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Title

Change in attention using the Wechsler Intelligence Scale

Description

Change in Cancellation scaled score of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Title

Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Description

Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Title

Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)

Description

Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Title

Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning

Description

Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Title

Change in language using Expressive Language Sampling

Description

Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline

Time Frame

6 Months post-implant

Secondary Outcome Measure Information:

Title

Rate of procedure and device-related adverse events

Description

Time Frame

Implant through 12 Months post-implant

Title

Change in Obstructive Sleep Apnea (OSA)

Description

Time Frame

3, 6, 12 Months post-implant

Title

Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires

Description

Quality of life improvements will be measured using the OSA-18 and ESS-CHAD. Mean scores for each questionnaire will be reported at baseline and 12 months post-implant.

Time Frame

12 months post-implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Down syndrome Age 10-21 years Prior adenotonsillectomy Severe OSA (AHI > 10, AHI < 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation Children and their parents/guardians must be proficient in English Exclusion Criteria: Body mass index (BMI) above the 95th percentile for subject's age Circumferential airway collapse at the level of the velopharynx observed during DISE Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration) Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest Patients with another implantable device which could interact unintentionally with the Inspire system Any contraindication for general anesthesia History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries Subject is currently taking muscle relaxant medication Life expectancy less than 12 months Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling Subjects with a co-occurring diagnosis of autism spectrum disorder Subjects that have a positive β-HCG Subjects deemed unfit for participation by the investigator for any other reason

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mike Swierzewski, MS

Phone

612-325-9723

michaelswierzewski@inspiresleep.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gwen Gimmestad

Phone

763-392-9966

gwengimmestad@inspiresleep.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Hartnick, MD

Organizational Affiliation

The Massachusetts Eye and Ear Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Healthcare of Atlanta/ Emory University School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nikhila Raol, MD

Nikhila.p.raol@emory.edu

First Name & Middle Initial & Last Name & Degree

Saria Matthews, CRC

saria.matthews@emory.edu

Facility Name

Massachusetts General Hospital (Mass Eye & Ear Infirmary)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Odeta Dyrmishi, MPA

Odeta_Dyrmishi@meei.harvard.edu

First Name & Middle Initial & Last Name & Degree

Chris Hartnick, MD

First Name & Middle Initial & Last Name & Degree

Brian Skotko, MD

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashley B Williams

WILLIAMSAB@chop.edu

First Name & Middle Initial & Last Name & Degree

Lisa M Elden, MD

Facility Name

Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Allison Tobey, MD

allison.tobey@chp.edu

First Name & Middle Initial & Last Name & Degree

Amber Shaffer, PhD

Phone

412-692-6874

shafferad@upmc.edu

Facility Name

University of Texas Southwestern/Children's Hospital of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75207

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ron Mitchell, MD

ron.mitchell@UTSouthwestern.edu

First Name & Middle Initial & Last Name & Degree

Francesca Chambers

francesca.chambers@childrens.com

Facility Name

Children's Hospital of the King's Daughters/East Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

32507

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Baldassari, MD

cristina.baldassari@chkd.org

First Name & Middle Initial & Last Name & Degree

Laura Stone, RN, BSN, CCRC

Phone

757-388-6238

stonelj@evms.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

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