AutoSet for Her Clinical Trial Protocol

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Standard AutoSet algorithm; Device: Modified AutoSet algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01826513

MA13245678

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.

Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.

User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal females aged ≥ 18 years
• Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry
• Diagnostic PSG available
• Diagnosis of mild-moderate OSA (AHI ≤ 30)
• Participants willing and able to give written informed consent

Exclusion criteria

• Participants currently using Bi-level PAP

• Participants currently using supplemental oxygen

• Participants who are pregnant

• Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

• Participants who the researcher believes are unsuitable for inclusion because either:

  • they do not comprehend English
  • they are unable to provide written informed consent
  • they are physically unable to comply with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 3 patient groups

Unblinded Investigational Arm

Experimental group

Description:

Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).

Treatment:

Device: Modified AutoSet algorithm

Standard AutoSet algorithm

Active Comparator group

Description:

Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.

Treatment:

Device: Modified AutoSet algorithm

Device: Standard AutoSet algorithm

Modified AutoSet algorithm

Experimental group

Description:

Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.

Treatment:

Device: Modified AutoSet algorithm

Device: Standard AutoSet algorithm