An interventional study of Nasal High flow therapy device in Sleep Disordered Breathing and Congestive Heart Failure, sponsored by Fisher and Paykel Healthcare. Terminated at 2 sites in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-08.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Basic science
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
The purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen.
Heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 6 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies with Cheyne-Stokes respiration (CSR) are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Device: Nasal High flow therapy device
Nasal high flow therapy via nasal cannula.
Treatment Efficacy
The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.
Time frame: During 1 night of Sleep on PSG
| Milestone | Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy |
|---|---|
| Started | 6 |
| Completed | 3 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 2 |
The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy | — | 0/6 (0%) | 0/6 (0%) |
From the 6 participants, 2 withdrew consent before participating in the study. 1 was lost to follow up as the participant did not turn up to his appointment.
| Age, Continuous(years) | Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy |
|---|---|
| Mean | 56.3 ± 8.73 |
| Sex: Female, Male(Participants) | Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy |
|---|---|
| Female | 0 |
| Male | 3 |
This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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