NCT03280914

Brief Summary

This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 6, 2020

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

August 14, 2017

Last Update Submit

February 5, 2020

Conditions

Keywords

obstructive sleep apneareal worldcommunity

Outcome Measures

Primary Outcomes (4)

  • Health assessment

    Health assessment would be performed by 36-Item Short-Form Health Survey.

    From 1st Aug 2017 to 31st Dec 2020

  • Sleep quality

    Sleep quality would be performed by Pittsburgh Sleep Quality Index.

    From 1st Aug 2017 to 31st Dec 2020

  • Psychological assessment

    Psychological assessment would be performed by Hospital Anxiety and Depression Scale.

    From 1st Aug 2017 to 31st Dec 2020

  • Control rate of hypertension

    From 1st Aug 2017 to 31st Dec 2020

Secondary Outcomes (3)

  • Incidence of chronic diseases

    From 1st Aug 2017 to 31st Dec 2025

  • Death from all-cause

    From 1st Aug 2017 to 31st Dec 2025

  • Medical cost

    From 1st Aug 2017 to 31st Dec 2025

Study Arms (2)

CPAP group

Automatic Continuous Positive Airway Pressure treatment and usual care

Device: Auto-CPAP

Usual care group

Usual care without Continuous Positive Airway Pressure treatment

Interventions

Auto-CPAPDEVICE

Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea

CPAP group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients would be recruited from Community of Huanghua Road.

You may qualify if:

  • \) AHI \>= 5 events/h

You may not qualify if:

  • Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
  • Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
  • Patients receiving CPAP treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community of Huanghua Road

Guangzhou, 510000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum lipid, glucose.

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertensionObesityDiabetes MellitusFatigue Syndrome, ChronicSleep Initiation and Maintenance DisordersPatient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Qiong Ou, M.D.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

September 13, 2017

Study Start

August 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.

Locations