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Completed

NCT Number: NCT03221387

Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. This pilot study will test the feasibility of using this therapy in the outpatient setting and its effects on sleep.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory failure, specifically those discharged to home following hospitalization for an acute exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or improves gas exchange long term in patients with COPD is lacking. Similarly, data that demonstrates that this therapeutic regimen is feasible to provide to patients in the home environment are lacking. This is an open-labeled pilot study of thirty patients to determine the safety and feasibility of using the device in the outpatient management of patients with COPD. A subset of ten patients will have serial sleep studies to determine the effects, if any, on sleep.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks
  • have COPD as the primary diagnosis
  • have smoked > 10 pack years.
  • receiving supplemental oxygen as part of their usual clinical care.
  • willing to give informed consent

Exclusion criteria

  • upper airway or nasal problems that prohibit the use of high flow oxygen
  • current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)
  • sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI > 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot);
  • excessive daytime sleepiness (i.e., either of High (>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 months).

Treatment and study plan

Humidified nasal high flow with oxygen

Device

The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.

Other names: AIRVO 2

Primary outcomes

  1. Use of Oxygen Therapy by HNHF-O2 at Home

    Time frame: 90 days

    Number of hours of use of the device per day as recorded on the device

Secondary outcomes

  1. Spirometry

    Time frame: 90 days

    Change in FEV1

  2. Change in 6 Minute Walk Distance

    Time frame: 90 days

    Total distance walked in 6 minutes

  3. Breathlessness

    Time frame: 90 days

    Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath

Other outcomes

  1. Sputum Quantity

    Time frame: Measured daily for 90 days

    Volume of sputum

  2. Sputum Consistency

    Time frame: Measured daily for 90 days

    Watery, thin, thick, none, no report made

  3. Sputum Color

    Time frame: Measured daily for 90 days

    Clear, yellow, brown, white, none

  4. Peak Flow

    Time frame: Measured daily for 90 days

    liters/minute

  5. Body Temperature > 100 Degrees F

    Time frame: Measured daily for 90 days

    Yes/no Subjects recorded body temperature via thermometer

  6. Presence of Cough

    Time frame: Measured daily for 90 days

    Yes/no

  7. Presence of Wheeze

    Time frame: Measured daily for 90 days

    Yes/no

  8. Presence of Sore Throat

    Time frame: Measured daily for 90 days

    Yes/no

  9. Presence of Nasal Congestion

    Time frame: Measured daily for 90 days

    Yes/no

  10. Polysomnography

    Time frame: 70 days

    Heart rate

  11. Polysomnography

    Time frame: 70 days

    Pulse oximetry

  12. Polysomnography

    Time frame: 70 days

    Total sleep time in hours

  13. Polysomnography

    Time frame: 70 days

    Sleep efficiency (percent of time sleeping/total amount of time in bed)

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (&lt 12 Wks.) Hospitalization for AECOPD for 90 Days

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2017
Registry last updated
Jun 7, 2021

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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