Comorbid Insomnia and Sleep Apnea

Comorbid Insomnia and Sleep Apnea in Patients Referred to Polysomnography

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia; Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Anticipated): 215

Contacts and Locations

• Study Contact: Name: Pedro Genta; Phone Number: 5511 993437027; Email: prgenta@gmail.com
• Study Contact Backup: Name: Marcela Yanagimori; Phone Number: 1155 963600111

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403900
      • Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
      • Contact: Pedro R Genta, MD; Phone Number: 551126625486; Email: prgenta@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Apnea
• Other Study ID Numbers: Insomnia-OSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No