Skip to content

DISE-PhOP 2

Predictive Value of Pharyngeal Opening Pressure for Surgical Outcomes in Patients with Obstructive Sleep Apnea and Failure or Intolerance to CPAP Therapy - DISE-PhOP 2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON61267
Enrollment
150
Registered
2026-05-04
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA) Sleep Apnea

Interventions

During drug-induced sleep endoscopy (DISE), patients will briefly wear a CPAP mask. The air pressure is then gradually increased, and we determine at which pressure the airway reopens. This pressure i
the examination only takes a few minutes longer. No extra appointments are required.

Sponsors

OLVG
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Scheduled for DISEAge = 18 years;AHI = 15 events per hour;Failure of, or intolerance to, PAP therapy;Central and mixed sleep apnea events accounting for less than 25% of the total AHIBody mass index (BMI) = 35 kg/m²

Exclusion criteria

Exclusion criteria: History of upper airway surgery that could alter DISE interpretation and surgical treatment outcomes, except for prior tonsillectomy and/or adenoidectomy;Current pregnancy;Inability or unwillingness to provide written informed consent;Contraindications to general anesthesia or to surgical procedures.

Design outcomes

Primary

MeasureTime frame
Dichotomous: Therapy success at 1 year (yes/no) following HGNS treatment, defined according to the Sher criteria (10):=50% reduction in AHI compared to baseline andPostoperative AHI <20 events/hour.Continuous: Postoperative AHI (events/hour)

Secondary

MeasureTime frame
Postoperative AHI Overall AHI (events/hour)AHI in supine position (events/hour)AHI in non-supine position (events/hour)PhOP measure (cm H20)

Countries

Netherlands

Contacts

Public ContactJ.A. Velde-Muusers

OLVG

researchkno@olvg.nl020 4807423

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026