Personalised Treatment for OSA

NCT06915077 | Enrolling By Invitation DMC

• 1 other identifier: EDGE 3513
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a sleep disorder characterized by repetitive episodes of partial or complete obstruction of the upper airway during sleep. Continuous positive airway pressure (CPAP) is a method used as a first-line treatment for obstructive sleep apnea (OSA). However, intolerance and resistance to CPAP can limit its long-term effectiveness. Alternative treatments are available, such as Mandibular Advancement Devices (MADs), positional therapy, upper airway surgery, and maxillomandibular osteotomy. However, often less efficient in reducing the apnea-hypopnea index, the higher tolerance of and compliance to alternative treatment has resulted in the adequate treatment of OSA in CPAP-intolerant patients. This paper describes the protocol of a prospective single-center cohort study including adult patients with moderate to severe OSA (15 events/h ≤ apnea-hypopnea index (AHI) \< 65 events/h) that failed to comply with CPAP therapy. Selected patients will be invited to the clinic to explore alternative treatment options where DISE will be a first step in further identifying upper airway collapse during sleep. By exploring alternative treatment options in CPAP-intolerant patients and systematically documenting their treatment paths, an algorithm can be defined to better guide patients towards personalized treatment for OSA. The follow-up is aimed at 5 years with an inclusion of 170 patients per year, including a drop-out rate of 15%. By leveraging a real-world database, this study aims to bridge the gap between research and clinical practice, facilitating the development of evidence-based guidelines and personalized treatment algorithms for CPAP-intolerant patients.

Conditions

Sleep Apnea Syndrome (OSAS); Sleep Apnea Syndrome; Sleep Apnea Syndrome, Obstructive; Sleep Apnea/Hypopnea Syndrome; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI) as measured by a poly(somno)graphy

  The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep.

  From baseline to 3 and 12 months

Secondary Outcomes (5)

• Reason for CPAP intolerance

  At baseline

• Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire

  From baseline to 3 and 12 months

• Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire

  From baseline to 3 and 12 months

• Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire

  From baseline to 3 and 12 months

• DISE-score during baseline DISE

  At baseline

Eligibility Criteria

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

Study Population

Adult patients (age starting from 18 years old) with moderate to severe OSA (AHI ≥ 15/h) who have been shown to be CPAP-intolerant or non-compliant and are willing to explore alternative treatment options.

You may qualify if:

• adult patients (age starting from 18 years old)
• moderate to severe OSA (AHI ≥ 15/h)
• CPAP-intolerant or non-compliant
• willing to explore alternative treatment options

You may not qualify if:

• patients who are still on CPAP therapy
• pediatric patients
• newly diagnosed patients who have not had CPAP before
• patients with AHI ≥ 65 events/h.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Universiteit Antwerpen

Wilrijk, Antwerpen, 2610, Belgium

Location

Related Publications (1)

• Van Daele M, Smolders Y, Van Loo D, Bultynck C, Verbraecken J, Vroegop A, Lapperre T, Op de Beeck S, Dieltjens M, Vanderveken OM. Personalized Treatment for Obstructive Sleep Apnea: Beyond CPAP. Life (Basel). 2024 Aug 13;14(8):1007. doi: 10.3390/life14081007.

  PMID: 39202749 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: April 8, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)