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Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome

Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome - Cross-sectional Observational Study on Association between Suitability of CPAP Mask and Morphology of Face in Japanese Patients with Sleep Apnea Syndrome (MFIT Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000022643
Enrollment
50
Registered
2016-06-07
Start date
2016-06-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Sleep Apnea Syndrome

Interventions

None listed

Sponsors

The Center for Sleep Disordered Breathing, Komagamine Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patient with sleep apnea syndrome (SAS) (2) Patient who continued continuous positive airway pressure (CPAP) therapy for 1 year or more at informed consent (IC) acquisition. (3) Patient who used only one model and one size of mask for CPAP therapy for 1 year or more at IC acquisition. (4) Patients whose prescription on CPAP therapy [pressure, operation mode, expiratory pressure relief (EPR)] was not changed for 1 year or more at IC acquisition. (5) Patients who used Autoset C, Sleepmate S9 Elite or Sleepmate S9 Auto for CPAP therapy. (6) Patients whose operation mode of equipment for CPAP therapy was CPAP mode. (7) Patients whose age was 20 years or more at IC acquisition. (8) Patients who gave written IC.

Exclusion criteria

Exclusion criteria: (1) Patients incapable of measuring accurate leak by opening mouth during CPAP therapy. (2) Patient with or suspected of nasal obstruction. (3) Patients for whom it's difficult to answer right by dementia and/or psychological disorder. (4) Patient receiving public assistance. (5) Patient with a history of epileptic seizure. (6) Patients whom the attending physician has considered ineligible for this study.

Design outcomes

Primary

MeasureTime frame
Morphology of face. - Nose breadth - Nasal root breadth - Nasal root depth

Secondary

MeasureTime frame
Evaluation of pain by Verbal Rating Scale (VRS) Physical size (Height, Weight, Body Mass Index(BMI)) CPAP Treatment data (Leak, Hour of use, Apnea Hypopnea Index (AHI), Model of CPAP, Model and size of mask, CPAP pressure, History of CPAP therapy, History of mask usage)

Countries

Japan

Contacts

Public ContactKiyoshi Moriyama

Komagamine Clinic The Center for Sleep Disordered Breathing

moriyama@ibiki-mukokyu.jp03-5333-8595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026