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Humidification Needs

NCT03247907 — Not applicable, Terminated, 10 participants, Fisher and Paykel Healthcare
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RegistryNCT03247907
StatusTerminated - Trial was terminated by investigators due to equipment difficulties
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, other
Enrollment10 (Actual)
SponsorFisher and Paykel Healthcare (Industry)
ConditionsObstructive Sleep Apnea
InterventionsCondition A: CPAP with No Humidification, Condition B: CPAP with No Humidification, Condition C: CPAP with Cold Passover, Condition D: CPAP with Modified humidifier, Condition E: CPAP with Ambient Tracking, Condition F: CPAP with Heated Humidification, Condition G: CPAP with Heated Humidification, Condition H: CPAP with New level humidification (Device)
Datesstart 2017-10-09, primary completion 2018-09-30, completion 2018-09-30, first posted 2017-08-14, last updated 2019-04-19
Locations1 site in New Zealand

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-Summary

A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.

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+Arms and interventions

ArmTypeInterventionsDescription
Condition A: CPAP with No HumidificationActive comparatorDevice: Condition A: CPAP with No HumidificationCPAP with No Humidification with no mouth leak
Condition B: CPAP with No HumidificationActive comparatorDevice: Condition B: CPAP with No HumidificationCPAP with No Humidification with mouth leak
Condition C: CPAP with Cold Passover humidifierActive comparatorDevice: Condition C: CPAP with Cold PassoverCPAP with Cold Passover humidifier with mouth leak
Condition D: CPAP with Modified HumidifierActive comparatorDevice: Condition D: CPAP with Modified humidifierCPAP with Modified Humidifier with mouth leak
Condition E: CPAP with Ambient TrackingActive comparatorDevice: Condition E: CPAP with Ambient TrackingCPAP with Ambient Tracking with mouth leak
Condition F: CPAP with Heated HumidificationActive comparatorDevice: Condition F: CPAP with Heated HumidificationCPAP with Heated Humidification at default setting with mouth leak
Condition G: CPAP with Heated HumidificationActive comparatorDevice: Condition G: CPAP with Heated HumidificationCPAP with Heated Humidification at max setting with mouth leak
Condition H: CPAP with New level humidificationActive comparatorDevice: Condition H: CPAP with New level humidificationCPAP with New level humidification with mouth leak
  • Condition A: CPAP with No Humidification (Device): CPAP with No Humidification with no mouth leak
  • Condition B: CPAP with No Humidification (Device): CPAP with No Humidification with mouth leak
  • Condition C: CPAP with Cold Passover (Device): CPAP with Cold Passover with mouth leak
  • Condition D: CPAP with Modified humidifier (Device): CPAP with Modified humidifier with mouth leak
  • Condition E: CPAP with Ambient Tracking (Device): CPAP with Ambient Tracking with mouth leak
  • Condition F: CPAP with Heated Humidification (Device): CPAP with Heated Humidification at default setting with mouth leak
  • Condition G: CPAP with Heated Humidification (Device): CPAP with Heated Humidification at max setting with mouth leak
  • Condition H: CPAP with New level humidification (Device): CPAP with New level humidification with mouth leak

+Outcome measures

Primary outcomes

  • Nasal Resistance [8 Days]: Will be measured by rhinomanometer or acoustic rhinometry
  • Evaluation of Nasal Dryness and Discomfort [8 Days]: Reported by participants using the Xero Questionnaire

Secondary outcomes

  • Preference of Testing Condition [8 Days]: Measured by custom preference questionnaire

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Aged 18 and over

Exclusion Criteria:

* Inability to give consent
* Currently pregnant or think they may be pregnant
* Current nasal symptoms or chronic nasal disease
* Contraindicated for PAP therapy

+Locations (1)

FacilityCityCountryStatus
Fisher and Paykel HealthcareEast Tamaki, AucklandNew Zealand

My Notes