Virtual Surgery of the Upper Airways

NCT04829201 | Unknown

• 1 other identifier: RCN303218
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Obstructive sleep apnea (OSA) is a sleep related breathing disorder caused by repetitive collapses of the upper airways resulting in impaired breathing, oxygen desaturation and sleep disturbances. OSA has a massive impact on global health contributing directly to cardiovascular diseases, insulin resistance, metabolic syndrome and daytime fatigue and is repeatedly associated with an increase in motor vehicle accidents. The mainstay of treatment is still the use of positive airway pressure or surgery of the upper airways, but the success rate is persistently low. Surgery may be of help, but there is a lack of patient-specific options in both diagnostics and treatment. Mathematical and computational modeling is expected to provide significant insight into the airway function and onset of OSA. This study is part of a project that will rely on biomedical engineering to obtain the required insight to produce software tools for computer-aided diagnostics and treatment of OSA.

Conditions

Sleep Apnea, Obstructive

Keywords

Surgery; Rhinoplasty; Nasal Obstruction; Soft tissue biomechanics

Outcome Measures

Primary Outcomes (2)

• Change in Apnea-Hypopnea Index (AHI)

  AHI is measured by sleep polygraphy in all patients before and after surgery

  Baseline and 3 months postoperatively

• Upper airway soft tissue characteristics

  Specific descriptions of deformation and strain in soft tissues in sleep apnea patients

  Up to 3 months postoperatively

Study Arms (1)

Obstructive sleep apnea (OSA)

OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery

Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery

Interventions

functional septorhinoplasty or oropharyngeal/orthognathic surgery PROCEDURE

obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea

Obstructive sleep apnea (OSA)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients within the community of Mid-Norway referred to the sleep clinic from primary or secondary care facilities.

You may qualify if:

• Obstructive sleep apnea
• need either functional septorhinoplasty or oropharyngeal/orthognathic surgery in order to establish adequate airway patency
• have undergone sleep registration using polysomnography and ultrawideband radar
• on the subsequent clinical evaluation presenting either 1) intranasal obstruction, due to malalignment of the nasal septal cartilage or the nasal outer framework; and/or 2) oropharyngeal obstruction or retrognathia.

You may not qualify if:

• previous nasal or oropharyngeal surgery
• previous use of nasal decongestant or nasal topical steroids over the last 3 months

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• SINTEF Health Research: collaborator
• St. Olavs Hospital: collaborator

Study Sites (2)

St Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

RECRUITING

Aleris Solsiden

Trondheim, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Soft tissue specimen from upper airways; soft palate and tonsils

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Nasal Obstruction

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Bjørn H Skallerud, phd prof

  NTNU, Fac IV, Dept of Structural Engineering

  STUDY DIRECTOR

• Ståle Nordgård, phd prof

  NTNU, Fac MH, Dept of Neuromedicine and Movement Science

  PRINCIPAL INVESTIGATOR

• Bernhard Müller, phd prof

  NTNU, Fac IV, Dept of Energy and Process Engineering

  PRINCIPAL INVESTIGATOR

• Sverre G Johnsen, phd

  SINTEF Health Research

  PRINCIPAL INVESTIGATOR

• Ståle Nordgård, phd prof

  St Olavs Hospital, Clinic Ear Nose and Throat

  STUDY DIRECTOR

Central Study Contacts

Mads HS Moxness, md phd

CONTACT

+47 99035515; madsmox@gmail.com

Ståle Nordgård, phd prof

CONTACT

0047 72880232; stale.nordgard@ntnu.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: April 2, 2021
• Study Start: April 20, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: third quarter 2022 until the end of 2024
• Access Criteria: links to all publications will be made available on the website

Locations

NO (2)