Trial Outcomes & Findings for Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep (NCT NCT02152566)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

During 1 night of Sleep on PSG

Results posted on

2016-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy 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 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. Nasal High flow therapy device: Nasal high flow therapy via nasal cannula.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy 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 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. Nasal High flow therapy device: Nasal high flow therapy via nasal cannula.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy n=3 Participants 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 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. Nasal High flow therapy device: Nasal high flow therapy via nasal cannula.
Age, Continuous	56.3 years STANDARD_DEVIATION 8.73 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: During 1 night of Sleep on PSG

Population: Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.

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.

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Rachel Vicars

Fisher & Paykel Healthcare

Phone: 09 574 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place