Comorbid Insomnia and Sleep Apnea

NCT ID: NCT04274400

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-06-01

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients referred for polysomnography

Patients referred for polysomnography will be classified according to the presence of OSA, insomnia or both.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pedro Rodrigues Genta

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Pedro Genta

Role: CONTACT

5511 993437027

Marcela Yanagimori

Role: CONTACT

1155 963600111

Facility Contacts

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Pedro R Genta, MD

Role: primary

551126625486

Other Identifiers

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Insomnia-OSA

Identifier Type: -

Identifier Source: org_study_id

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