NCT01901055

Brief Summary

Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 13, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 13, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

5.2 years

First QC Date

July 10, 2013

Results QC Date

May 3, 2021

Last Update Submit

August 13, 2021

Conditions

Type 2 DiabetesObstructive Sleep Apnea

Keywords

sleep apneadiabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1C Level

    Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.

    baseline, 6 weeks, 12 weeks

Secondary Outcomes (10)

  • Fructosamine Level

    baseline, 6 weeks, 12 weeks

  • Diabetes Diet Adherence

    baseline, 6 weeks, 12 weeks

  • Diabetes Knowledge

    baseline,12 weeks only

  • Self-Monitoring of Blood Glucose (SMBG)

    baseline, 6 weeks, 12 weeks

  • Steps Walked

    baseline, 6 weeks, 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Active CPAP treatment

EXPERIMENTAL

Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)

Device: CPAPBehavioral: Diabetes Education

Sham-CPAP

PLACEBO COMPARATOR

Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.

Device: CPAPDevice: Sham-CPAPBehavioral: Diabetes Education

Interventions

CPAPDEVICE

CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

Also known as: Continuous Positive Airway Pressure
Active CPAP treatmentSham-CPAP
Sham-CPAPDEVICE

Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

Also known as: Sham Continuous Positive Airway Pressure
Sham-CPAP
Diabetes EducationBEHAVIORAL

Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)

Active CPAP treatmentSham-CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suboptimal glucose control (A1C ≥ 6.5%)
  • Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index \>= 10/hour)
  • age 18 years and older

You may not qualify if:

  • Poor glucose control (A1C \> 11)
  • Type 1 or gestational diabetes
  • Sleep duration \< 4 hrs
  • Acute medical or surgical conditions or hospitalization ≤ 3 months
  • Oxygen or bi-level PAP required
  • Prior CPAP or persons in household with CPAP
  • Employed in safety sensitive job
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

John D. Dingell VAMC

Detroit, Michigan, 48201, United States

Location

Pittsburgh Veterans Administration Medical Center

Pittsburgh, Pennsylvania, 15240, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (2)

  • Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9.

    PMID: 34105104DERIVED

  • Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2.

    PMID: 30517889DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sleep Apnea, ObstructiveSleep Apnea SyndromesDiabetes Mellitus

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Limitations and Caveats

Recruitment was negatively affected by a large number of persons screened who were ineligible because of either their, or a family member, having prior CPAP treatment. Recruitment was also affected by persons who did not want the possibility of being randomized to be on a sham-CPAP device for 12 weeks.

Results Point of Contact

Title
Eileen R. Chasens, PhD, Professor of Nursing
Organization
University of Pittsburgh
chasense@pitt.edu
412-624-9380

Study Officials

  • Eileen R. Chasens, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Nursing

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

February 13, 2014

Primary Completion

May 8, 2019

Study Completion

May 8, 2019

Last Updated

August 16, 2021

Results First Posted

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)