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Otolaryngology Clinical Trials

HGN Study

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

Conditions: Obstructive Sleep Apnea and Down Syndrome

Type of Research: Interventional
Principal Investigator: Cristina Baldassari, MD

Study Specifications: Study of an implantable INSPIRE device for the treatment of Obstructive Sleep Apnea in patients with Down syndrome and previous adenoid and tonsil removal.

To participate, patient must meet the following qualifications, amongst others:

  • Ages 10-21
  • Diagnosed with Down Syndrome
  • Diagnosed with severe Obstructive Sleep Apnea
  • Previous tonsil and adenoid removal

Email: EnuguL@ODU.edu
Phone: (757) 388-6264

DOSA Study

Randomized Control Trial of Oxygen Therapy in Children and Adolescents with Down Syndrome and Obstructive Sleep Apnea

Conditions: Obstructive Sleep Apnea and Down Syndrome

Type of Research: Interventional
Principal Investigator: Cristina Baldassari, MD

Study Specifications: Oxygen Therapy vs. supportive care in children who have Down Syndrome and moderate/severe Obstructive Sleep Apnea diagnosed by Polysomnogram (sleep study).

To participate, patient must meet the following qualifications, amongst others:

  • Ages 5-17
  • Diagnosed with Down Syndrome
  • Diagnosed with moderate/severe Obstructive Sleep Apnea
  • Previous tonsil and adenoid removal

Email: JonesMJ@ODU.edu
Phone: (757) 688-7379

TOPS Study

Treatment of Obstructive Sleep Apnea with Personalized Surgery in Children with Down Syndrome

Conditions: Obstructive Sleep Apnea and Down Syndrome

Type of Research: Interventional
Principal Investigator: Cristina Baldassari, MD

Study Specifications: Adenoid and Tonsil Removal vs. Drug-Induced Sleep Endoscopy (DISE) - directed surgery in children who have Down Syndrome and Obstructive Sleep Apnea diagnosed by Polysomnogram (sleep study).

To participate, patient must meet the following qualifications, amongst others:

  • Ages 2-17
  • Diagnosed with Down Syndrome
  • Diagnosed with Obstructive Sleep Apnea
  • No previous tonsil removal

Email: JonesMJ@ODU.edu
Phone: (757) 688-7379

Bedwetting Study

Adenoid and Tonsil Removal vs. Bed Alarm for Children with Nocturnal Enuresis (Bedwetting)

Conditions: Sleep-Disordered Breathing and Nocturnal Enuresis

Type of Research: Interventional
Principal Investigator: Cristina Baldassari, MD

Study Specifications: Tonsil and Adenoid removal vs. bedwetting alarm in children who have sleep-disordered breathing and enlarged tonsils & adenoids with Nocturnal Enuresis.

To participate, patient must meet the following qualifications, amongst others:

  • Ages 2-17
  • Has sleep-disordered breathing (snoring, gasping while sleeping, etc.) and/or diagnosed with mild/moderate Obstructive Sleep Apnea
  • Has Nocturnal Enuresis at least 2-3 times per week.
  • No previous tonsil and adenoid removal

Email: JonesMJ@ODU.edu
Phone: (757) 688-7379