Wisconsin Sleep Cohort Study

Operations and Procedure Manual

This is an accordion element with a series of buttons that open and close related content panels.

Overall Sampling Design

  1. Survey of 4 Dane County, WI State agency full-time employees aged 30–60 (1989–1993)
  2. 71% Response rate (n=4896) eligible for recruitment into Wisconsin Sleep Cohort Study
  3. Stratified sampling based on snoring status to over-weight the sample with individuals likely to have sleep disordered breathing (n=2884)
  4. Wisconsin Sleep Cohort Study (n=1545), initial overnight polysomnography study (1989–2003)

Protocol History

Instrument History (in Time Order)

Mailed Surveys

Polysomnography (PSG) study (1989-2015)

  1. Resources
    1. Sleep Lab Description
  2. Recruitment/Administration
    1. Overall description of Cohort Selection Procedures
    2. Invitation Letters
      1. 1st visit
      2. 2nd visit
      3. Negative responder
    3. Intake form
    4. Response card
    5. Reminder letters
      1. Overnight visit with Clinical MSLT & 24 hour BP
      2. Overnight visit with Clinical MSLT & no 24 hour BP
      3. Overnight visit with no MSLT
      4. 24 hour blood pressure study
      5. Research Multiple Sleep Latency Test
    6. Report letters
      1. Current overnight letter accompanying sleep report
      2. Current sample overnight sleep report
      3. Overnight visit (old)
      4. Overnight visit (new)
      5. Overnight Sleep Summary included with letter
    7. Consent forms
      1. Overnight study
      2. Multiple Sleep Latency Test
      3. 24 hour blood pressure study
    8. Thank you letter / Enclosed comment form for overnight study
    9. Exclusion letter
      1. Description
      2. History and Physical Form
  3. Overall Overnight Protocol
  4. Self-Report Instruments
    1. Health Questionnaire / Coding / Field_codes
    2. Health Questionaire 7/18/2012 / Coding 7/18/2012
    3. Women’s Health Questionnaire (10/08/93 to 09/03/09) / Coding
    4. Zung Depression Questionnaire and Coding / Original Scoring Key
    5. State–Trait Anxiety Scale and Coding / Scoring Key 1-20 / Scoring Key 21-40 / Percentiles / Standardized Scores
    6. Epworth Sleepiness Scale
    7. Horne–Ostberg Morningness/Eveningness Scale / Coding
    8. PM Sleep Evaluation / Coding
    9. AM Sleep Evaluation / Coding
    10. Changes to Self-Reported Instruments
      1. Health Questionnaire
      2. Changes (in html)
      3. Changes (in Excel)
      4. Health Questionnaire Visit 1
      5. Health Quesitionnare Visit 1 (post 1993)
      6. Health Questionnaire Visit 2
      7. Health Questionnaire Visit 3+
  5. Protocols
    1. Overnight Polysomnography
      1. Resources
      2. Electrode Placement
      3. Airflow Sensor Usage/Jackbox Placement Protocol
      4. Grass Recording Montage Information / Electrode Visual
      5. Calibrations
      6. Scoring guidelines
      7. Additional criteria for scoring with GAMMA
      8. Data Management Procedures and Policy
      9. Protocol for CPAP users
      10. Medical Follow up for SDB
    2. Body Habitus Measurements
      1. Protocol
      2. Collection form / Coding
      3. Procedure Descriptions
    3. ECG
      1. Overview, Policies & Procedures, Sample ECG, Quality Control, Data Recording / ECG coding
      2. ECG Medical Alert Criteria
    4. Neuropsych
      1. Overall summary
      2. Individual Battery Description
      3. Testing Procedures
      4. AVLT form
      5. Grooved pegboard protocol & photo
      6. Trail Making Sample
      7. Symbol Digit Modality form
      8. Oral Word Controlled Association form
      9. Digit Cancellation form
      10. AVLT Recognition
      11. Test scoring Procedures
      12. Data form for entry into Database
    5. Blood Analyses
      1. Panel collected and Ranges
      2. Changes in protocol over time
    6. Blood Pressure Measurement
      1. Protocol
  6. Quality Control
    1. Data Collection Checklist
    2. Quality Control Policy and Procedures
    3. Sleep Data Management Procedures and Policies
  7. Historic Studies
    1. Peak Flow Meter Asthma Study
      1. Peak Flow Instructions
      2. Peak Flow Questionnaire
      3. Peak Flow Consent form
      4. Peak Flow Diary
  8. Database
    1. PSG data aggregated for the database

Multiple Sleep Latency Test (MSLT) (1989-2011)

  1. Recording procedures, scoring criteria and protocol
  2. Recording montage information
  3. Scoring review sheet
  4. Sleep Log Data sheet
  5. Volunteer Questionnaire
  6. Data sheet
  7. Stanford Sleepiness Scale
  8. Changes in protocol over time

Cardio Study (10/14/2004 - 12/31/2008)

Protocols

  1. Psychomotor Vigilance Test
    1. Overall description for PVT
    2. Specific procedure for PVT
    3. Sample PVT Report
    4. PVT Outcomes
  2. Cardiovascular
    1. Overall Protocol
    2. Brachial Artery Reactivity Study (Data Sheet, Report)
    3. Carotid Intima Media Thickness (CIMT) Studies (Report)
    4. Holter Monitor (For Heart Rate Variability): (Hook Up (Diagram), Data Analysis, Data Sheet)
    5. Retinal Photography (Questionnaire, Data Sheet)
    6. Cerebral Blood Flow: (Manual, Checklist)
  3. Ankle Brachial Blood Pressure Index
  4. Body Habitus Measurements
    1. Protocol
    2. Collection form
    3. Procedure Descriptions
  5. Blood Pressure Measurement
  6. Blood Draw: Prior to 1/1/2005, Post 1/1/2005

Questionnaires

  1. Health Questionnaire, (Coding)
  2. Women’s Health Questionnaire (Coding)
  3. Current Physical Activity Questionnaire (Coding)
  4. Past Physical Activity Questionnaire with Coding (Code sheet)
  5. Short Form 36 Health Status Questionnaire (Coding)
  6. Vision History Questionnaire (Coding)
  7. Atherosclerosis Risk in Communities (ARIC)
    1. Short Questionnaire
    2. Long Questionnaire
    3. Database Coding
  8. Self Evaluation Questionnaires
    1. Center for Epidemiologic Studies Depression Scale CESD-R20 (Coding)
    2. Profile of Mood States POMS (Coding)

Administrative Forms/Protocols

  1. Protocol for Abnormal Results
  2. Eye Pathology Notification Form
  3. Physicians Orders
    1. SDB, Metabolic Syndrome and Vascular Function
    2. Epidemiology of Sleep Disordered Breathing – Outpatient Outcomes Follow-up
  4. Consent Form – Cardio Protocols
  5. Consent Form – 24 Hour BP Study
  6. Research Authorization Form
  7. Medical Alert Criteria for Carotid Ultrasound

Metabolic Outcomes Study

Metabolic Outcomes Protocol

  1. Timeline
  2. Overall Protocol
  3. Gait and Balance (Data Sheet, Coding)
  4. Atherosclerosis Imaging (Quality Control) (Database Pulse Wave Fields) (Database Echocardiography) (Database Carotid Intima Media Thickness)
  5. Psychomotor Vigilance Test
    1. Setup Instructions
    2. Administration Instructions for PVT
    3. Data Download Procedure
    4. Sample PVT Report
    5. PVT Variables
  6. 12-lead ECG Procedure (Report Form, Coding)
  7. Ankle Brachial Blood Pressure Index
  8. Body Habitus Measurements
    1. Protocol
    2. Collection Form
    3. Coding
    4. Procedure Descriptions
  9. Blood Pressure Measurement
  10. Blood Draw: Prior to 1/1/2005, Post 1/1/2005
  11. Retinal Photography Field Codes

Metabolic Outcomes Questionnaires (7/18/2012 – 2014)

  1. Health Status Update 07/18/2012 (Coding)
  2. Current Physical Activity Questionnaire (Sheet, Coding)
  3. Short Form 36 Health Status Survey (Sheet, Coding)
  4. NHIS Falls and Balance (Coding)
  5. Center for Epidemiologic Studies Depression Scale CESD-R20 (Coding)
  6. Profile of Mood States POMS (Coding)
  7. Calgary Symptoms of Stress WSC version (Coding, Calgary Symptoms of Stress Inventory)
  8. Life Events (new 7/18/2012) (Coding)
  9. Eye Vision History (new in 2013) (Coding)

Metabolic Outcomes Questionnaires (2009-2012)

  1. Health Status Update (Coding)
  2. Current Physical Activity Questionnaire (Sheet, Coding)
  3. Short Form 36 Health Status Survey (Sheet, Coding)
  4. NHIS Falls and Balance (Coding)
  5. WSC Falls [discontinued] (Coding)
  6. Center for Epidemiologic Studies Depression Scale CESD-R20 (Coding)
  7. Profile of Mood States POMS (Coding)
  8. Calgary Symptoms of Stress WSC version (Coding, Calgary Symptoms of Stress Inventory)
  9. Louisville Older Persons Event Scale [discontinued] (Coding)

Administrative Forms/Protocols

  1. Protocol for Abnormal Results
  2. Eye Pathology Notification Form
  3. Physicians Orders
    1. SDB, Metabolic Syndrome and Vascular Function
    2. Epidemiology of Sleep Disordered Breathing – Outpatient Outcomes Follow-up
  4. Consent Form – Daytime Protocols
  5. ECG Medical Alert Criteria
  6. Research Authorization Form
  7. Medical Alert Criteria for Carotid Ultrasound

Retirement and Sleep Trajectories (REST) study (2010-2014)

Midlife Study (2019-2023)

PROTOCOLS/QUESTIONNAIRES

Body Habitus Measurements In-Home (Protocol, Data Form)

Current Physical Activity Questionnaire (Data Form)

ETDRS 2 Meter Acuity Test (Protocol, Data Form)

Falls and Balance Questionnaire (Data Form)

Grip Strength Test (Protocol, Data Form)

Hypersomnia Severity Index (Data Form)

Midife Sleep Health Questionnaire (Data Form)

Near Vision Acuity (Protocol, Data Form)

Neurospych Test Battery In-Home (Summary,  Protocol, Scoring, Data Form)

PVT In-Home (Protocol)

Self-Evaluation Questionnaire (Data Form)

Sleep Diary (Instructions, Data Form)

Sleep Inertia Questionnaire (Data Form)

Social Environment Questionnaire (Data Form)

Test of Standing Balance In-Home (Protocol, Data Form)

TICS (Script and Form)

Timed Up and Go In-Home (Protocol, Data Form)

Visit Day Questionnaire (Data Form)

Falls – 4, 8, 12 month follow-up Post Cards (Data forms: 4m, 8m, 12m)

ADMINISTRATIVE FORMS/PROTOCOLS

Consent Form

HIPAA Form

Protocol for Reportable events

Phone script for In Home study visit