A Comparison of CPAP With and Without Humidification: A Pilot Study

NCT02423681 | Completed DMC

• 1 other identifier: CIA-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• Overall cost of equipment

  (cost of equipment required for CPAP therapy, including CPAP device and mask, and all related consumables

  6 months

• Number and type of additional interventions

  The number and type of additional interventions (masks, nasal steroids) and the associated cost

  6 months

• Duration of appointments

  Time spent with/on each patient (i.e preparation and follow-up time as well as appointment time)

  6 months

• Number of unplanned follow-ups

  number of unplanned follow-ups

  6 months

Secondary Outcomes (7)

• Adherence to therapy

  6 months

• Therapy Acceptance

  6 months

• Apnea Hypopnea Index (AHI)

  6 months

• Leak

  6 months

• Side effects and symptoms reported

  6 months

Study Arms (2)

Heated humidification as first intention (HH1st)

ACTIVE COMPARATOR

Subjects receive heated humidification as first intention with ThermoSmart

Device: ThermoSmart

Non-heated humidification

PLACEBO COMPARATOR

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

Interventions

ThermoSmart DEVICE

Heated humidification as first intention (HH1st) with ThermoSmart

Heated humidification as first intention (HH1st)

Without ThermoSmart DEVICE

ThermoSmart is switched off

Non-heated humidification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years of age
• Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI \> 5 with significant daytime sleepiness)
• Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
• Fluent in spoken and written English

You may not qualify if:

• Significant uncontrolled cardiac disease, as per the principal investigator's discretion
• Co-existing lung disease, as per the principal investigator's discretion
• Co-existing sleep disorder, such a predominant central sleep apnoea
• Pregnancy
• Participants that are unable or unwilling to give informed consent.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Lung Function and Sleep Unit, St George's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sara Parsons, Chief Clinical Physiologist

  Lung Function and Sleep Unit, St George's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

GB (1)