The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

NCT03075722 | Completed DMC

• 1 other identifier: CIA-205
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington. Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial. This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (7)

• Comfort

  Subjective questionnaire

  Up to 7 ± 3 days in-home

• Stability

  Subjective questionnaire

  Up to 7 ± 3 days in-home

• Objective leak data

  Obtained from participant's CPAP device

  Up to 7 ± 3 days in-home

• Subjective measurement of leak

  Subjective questionnaire

  Up to 7 ± 3 days in-home

• Draft

  Subjective questionnaire

  Up to 7 ± 3 days in-home

• Treatment efficacy

  Obtained from participant's CPAP device

  Up to 7 ± 3 days in-home

• Noise

  Subjective questionnaire

  Up to 7 ± 3 days in-home

Secondary Outcomes (2)

• Preference of mask

  Up to 7 ± 3 days in-home

• Usability

  Up to 7 ± 3 days in-home

Study Arms (1)

Saturn nasal mask

EXPERIMENTAL

Participants to use nasal mask in-home for 7 ± 3 days

Device: Saturn nasal mask

Interventions

Saturn nasal mask DEVICE

Nasal mask for the treatment of obstructive sleep apnea (OSA)

Saturn nasal mask

Eligibility Criteria

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

You may qualify if:

• Adult (18+ years of age)
• Able to give consent
• AHI ≥ 5 on diagnostic night
• Prescribed a CPAP device after successful OSA diagnosis
• Existing nasal or nasal pillow mask user

You may not qualify if:

• Inability to give consent
• Participants who are in a coma or a decreased level of consciousness.
• Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or may think they are pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Bowen Hospital

Wellington, 6035, New Zealand

Location

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 9, 2017
• Study Start: March 9, 2017
• Primary Completion: March 30, 2017
• Study Completion: April 15, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)