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Completed

NCT Number: NCT01826513

AutoSet for Her Clinical Trial Protocol

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West Australian Sleep Disorders Research Institute

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard AutoSet algorithm

Device

An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

Modified AutoSet algorithm

Device

An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Other names: AutoSet for Her

Primary outcomes

  1. Apnoea Hypopnoea Index (AHI)

    Time frame: 1 day

    Number of apnoeas and hypopnoeas per hour of sleep

  2. Oxygen Desaturation Index (ODI)

    Time frame: 1 day

    Number of oxygen desaturations per hour of sleep

Secondary outcomes

  1. Sleep Efficacy

    Time frame: 1 day

    Sleep time divided by total time available for sleep

  2. Wake After Sleep Onset Time

    Time frame: 1 day

    Time awake in minutes after initial sleep onset

  3. Time Taken to Fall Asleep

    Time frame: 1 day

    Time in minutes taken to fall alseep

  4. Number of Spontaneous Arousals

    Time frame: 1 day

    Number of spontaneous arousals occurring over the entire total sleep time

  5. Number of Hypopnoeas

    Time frame: 1 day

    Total number of hypopnoeas occurring in the total sleep time

  6. Number of Obstructive Apnoeas

    Time frame: 1 day

    Total number of obstructive apnoeas occurring in the total sleep time

  7. Number of Central Apnoeas

    Time frame: 1 day

    Total number of central apnoeas occurring in the total sleep time

  8. Oxygen Saturation

    Time frame: 1 day

    Oxygen saturation recorded in the total sleep time

  9. Percentage of Total Sleep Time Spent in Each Sleep Stage

    Time frame: 1 day

    Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)

  10. Number of Respiratory Event Related Arousals

    Time frame: 1 day

    Total number of respiratory event related arousals over the entire sleep period

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • The University of Western Australia

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2013
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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