Comorbid Insomnia and Sleep Apnea | NCT04274400

Studies
Comorbid Insomnia and Sleep Apnea

NCT04274400

Sponsor

University of Sao Paulo General Hospital

Status

Unknown status

Last Update Posted

Feb 18, 2020Actual

Enrollment

215Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea
Insomnia

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 13, 2020

First Posted Date

Feb 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pedro Rodrigues Genta, Associate Professor, University of Sao Paulo General HospitalPrincipal Investigator

Lead Sponsor

University of Sao Paulo General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Insomnia and OSA coexist in clinical populations, but the prevalence of comorbid insomnia among OSA patients in the community and risk factors remain poorly known. Little is known about the impact of sleep apnea and insomnia on the quality of life and quality of sleep compared to the presence of one of the sleep disorders alone. Our hypothesis is that the co-existence of OSA and insomnia is high in our community. We also hypothesized that the co-existence of OSA and insomnia promotes greater impairment of quality of life and quality of sleep when compared to the presence of OSA or insomnia alone.

Patients referred to polysomnography will be submitted to 6 questionnaires to assess daytime sleepiness (EPWORTH), insomnia severity index (ISI), anxiety and depression assessment (Beck's anxiety and depression inventory), quality of life assessment(WHOQOL- BREF) and sleep quality assessment (Pittsburgh questionnaire) and they will also be submitted to a polysomnography type III.

It will be calculated the frequency of insomnia, OSA and the comorbidity between insomnia and OSA in the sample. It will be analysed correlations between the insomnia severity index, apnea and hypopnea index, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck's anxiety and depression inventory) and Pittsburgh sleep quality scale. Insomnia severity index scores, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck anxiety and depression inventory) and Pittsburgh sleep quality scale will be compared according to the presence and absence of OSA and the presence and absence of insomnia and the presence of the comorbidity insomnia and OSA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients referred for polysomnography		Patients referred for polysomnography will be classified according to the presence of OSA, insomnia or both.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia	Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia	6 months

Secondary Outcomes

Measure	Description	Time Frame
Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire	Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Individuals who will participate in the task force for the diagnosis of sleep apnea promoted by the State Department of Health in an agreement signed with the Heart Institute

Exclusion Criteria:

individuals under 18 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals who will participate in the task force for the diagnosis of sleep apnea promoted by the State Department of Health in an agreement signed with the Heart Institute

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pedro Genta	Contact	5511 993437027		prgenta@gmail.com
Marcela Yanagimori	Contact	1155 963600111

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo		São Paulo	São Paulo	05403900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

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