N/A
N=42
A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
Sleep Apnea, Obstructive · Down Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02344108 ↗Enrolled (actual)
42
Serious AEs
16.7%
Results posted
Feb 2022
Primary outcome: Primary: Serious Adverse Events — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inspire® Upper Airway Simulation System (Model 3028 IPG ) (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Christopher Hartnick, M.D.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
7 | — |
| PRIMARY Non-Serious Adverse Events |
15 | — |
| PRIMARY Unanticipated Adverse Device Effects (UADE) |
— | — |
| SECONDARY Apnea-hypopnea Index (AHI) |
11.0; -12.9 | <0.0001 sig |
| SECONDARY Obstructive Apnea-hypopnea Index |
10.1; -12.2 | <0.0001 sig |
| SECONDARY Central Apnea Index |
0.87; -0.71 | 0.035 sig |
| SECONDARY Hypopnea Percentage |
80.3; 5.6 | 0.083 |
| SECONDARY Oxygenation Percentage of Time SpO2 < 90% |
0.6; -0.8 | 0.0021 sig |
| SECONDARY Percentage of Time ETCO2 > 50 mmHg |
14.0; -3.0 | 0.764 |
| SECONDARY SpO2 Nadir |
88.0; 3.2 | <0.0001 sig |
| SECONDARY Sleep Efficiency |
72.2; -2.3 | 0.467 |
| SECONDARY REM Percentage |
13.2; 0.4 | 0.745 |
| SECONDARY Arousal Index |
22.6; -2.0 | 0.106 |
| SECONDARY OSA-18 Total Survey Score |
31.3; -34.8 | <0.0001 sig |
| SECONDARY OSA-18 Overall Quality of Life Score |
8.1; 2.8 | <0.0001 sig |
| SECONDARY Epworth Sleepiness Scale (ESS) Survey Score |
5.0; -5.1 | <0.0001 sig |
Summary
Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is associated with adverse behavior and quality of life, as well as long term cardiopulmonary system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder, with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a higher incidence of OSA than the general pediatric population, with rates of 30-60%, resulting in increased morbidity and decreased quality of life for affected individuals. In children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent obstruction is attributed to anatomic and physiologic differences in this population, including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved under P130008 for the treatment of obstructive sleep apnea, which has already been approved for use in adults with OSA, can be safely implanted and used in adolescents and young adults with Down Syndrome.
Eligibility Criteria
Inclusion Criteria
- Only children and young adults with Down Syndrome age 10-21 years with prior adenotonsillectomy will be considered for the study.
- Subjects must have BMI 10, AHI 95th percentile for age, apnea hypopnea index (AHI) 50 on in-lab polysomnography (PSG), central or mixed apneas accounting for >25% of the total AHI, any anatomic finding on physical exam or drug induced sleep endoscopy (DISE) that would compromise the performance of stimulation (e.g. concentric soft palate collapse), other medical conditions resulting in medical instability (e.g. 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), history of cholesteatoma, or patients with another implantable device which could interact unintentionally with the Inspire system.
- Subjects in whom general anesthesia for a surgical procedure is contraindicated due to other medical illnesses or conditions will be excluded.
- Subjects with a life expectancy < 12 months will be excluded.
- Subjects who are unable to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment, will be excluded.
- Subjects with a history of bleeding or clotting disorders and those on blood thinning or NSAID medications will be excluded from participation.
- Subjects taking muscle relaxant medication will be excluded from participation.
- Female subjects who are pregnant or plan to become pregnant during the study period will be excluded. All female subjects will undergo urine beta-HCG testing on the day of procedures requiring general anesthesia (DISE, implantation, and any other unanticipated surgical procedures related to implantation). Subjects who are positive will not undergo surgical implantation or procedures under general anesthesia.
- Subjects deemed unfit for participation by investigators or any other reason will be excluded.
Data sourced from ClinicalTrials.gov (NCT02344108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.