Sleep Apnea and Gestational Diabetes

NCT ID: NCT02108197

Last Updated: 2018-01-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.

Detailed Description

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Conditions

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Gestational Diabetes Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP Intervention

Continuous positive airway pressure (S9, ResMed)

Group Type EXPERIMENTAL

Continuous positive airway pressure (S9, ResMed)

Intervention Type DEVICE

Wait-list

Wait list controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous positive airway pressure (S9, ResMed)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* gestational diabetes

Exclusion Criteria

* pre-gestational diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sirimon Reutrakul

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirimon Reutrakul, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Ramathibodi Hospital

Locations

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Faculty of Medicine Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Chirakalwasan N, Amnakkittikul S, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Thakkinstian A, Reutrakul S. Continuous Positive Airway Pressure Therapy in Gestational Diabetes With Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2018 Mar 15;14(3):327-336. doi: 10.5664/jcsm.6972.

Reference Type DERIVED
PMID: 29458699 (View on PubMed)

Other Identifiers

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11-56-39

Identifier Type: -

Identifier Source: org_study_id

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