NCT01025440

Brief Summary

Phase One: High Flow (HF) CPAP (HF-CPAP) Titration: Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the night. At the completion of night 3 participants will be categorized as responders or non-responders. Only responders will continue to Phase 2 of the investigation. Phase Two: HF-CPAP compared with CPAP: Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG. Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm. Thew following night participants will undergo the alternative treatment arm for the duration of the night.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

December 1, 2009

Last Update Submit

June 16, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Efficacy to treat OSA

    Nights 3, 4 and 5 (after each PSG)

Secondary Outcomes (2)

  • Sleep Quality

    Nights 3, 4 and 5 (after each PSG)

  • Participant Treatment Preference: HF-CPAP compared with CPAP

    Night 5

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: The CPAP pressure will be set to the individual subject's therapeutic pressure -as determined by PSG on Night 2. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)

Device: Continuous Positive Airway Pressure

HFCPAP

ACTIVE COMPARATOR

Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: During HF CPAP 35 L/min wil be administered. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway PressureDEVICE

Continuous Positive Airway Pressure (CPAP) Dose: A flow (35 L/min) or pressure (btw 4 and 20 cmH20 -individual to each subject) is set on the device. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required) Duration:

Also known as: Positive airway pressure
CPAPHFCPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥ 18 years.
  • AHI \> 15 events per hour and ≥ 90% of events must be Hypopneas.

You may not qualify if:

  • Any medical condition which contraindicates the use of CPAP or AutoCPAP. See Appendix D for this list.
  • Requires supplemental oxygen.
  • Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
  • Unstable psychiatric disease.
  • Other significant sleep disorder.
  • Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
  • Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
  • Participation in another clinical investigation in the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HELIOS-Klinik Hagen Ambrock

Ambrocker Weg 60, Hagen, D 58091, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • George Nilius, M.D

    HELIOS-Klinik Hagen Ambrock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 3, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

DE(1)