An interventional study of ThermoSmart and Without ThermoSmart in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Health services research
To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 20 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive 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:
Subjects receive heated humidification as first intention with ThermoSmart
Device: ThermoSmart
Subjects will receive no humidification. However they can be switched to the humidification group if patients complains of nasal dryness, congestion, nose bleed or if they had significant leak that cannot be resolved by two changes of mask.
Device: Without ThermoSmart
Heated humidification as first intention (HH1st) with ThermoSmart
ThermoSmart is switched off
Overall cost of equipment
(cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables
Time frame: 6 months
Number and type of additional interventions
The number and type of additional interventions (masks, nasal steroids) and the associated cost
Time frame: 6 months
Duration of appointments
Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)
Time frame: 6 months
Number of unplanned follow-ups
number of unplanned follow-ups
Time frame: 6 months
Adherence to therapy
Compliance data from the device
Time frame: 6 months
Therapy Acceptance
Number of withdrawals and drop out from the therapy
Time frame: 6 months
Apnea Hypopnea Index (AHI)
AHI to measure the treatment efficacy
Time frame: 6 months
Leak
Total system leak from the device
Time frame: 6 months
Side effects and symptoms reported
Any side effects and symptoms reported with the therapy
Time frame: 6 months
Self-reported satisfaction
Self-reported satisfaction via treatment questionnaires
Time frame: 6 months
Patient sleeping environment temperature and humidity
The temperature and humidity of the patient's environment as measured by a humidity logger
Time frame: 6 months
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare