Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

Status

Terminated

Phase

Phase 4

Enrollment

37 participants (actual)

Sponsor

University of Chicago · Other

Design

Randomized · Double masking

Countries

1 country

United States

Start

Sept 2003

Primary completion

Jun 2008

Completion

Jun 2008

First posted

20 Sept 2005 (estimated)

Last update posted

21 Mar 2023

Conditions

Polycystic Ovary Syndrome · Obstructive Sleep Apnea

Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated. The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.

• No intervention

  Aim 1: Placebo

  One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.

• Experimental

  Aim 1: Pioglitazone

  One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.

• Experimental

  Aim 1: Leuprolide + Estrogen/Progestin

  One of the 3 treatment arms in Aim 1: depot leuprolide plus estrogen/progestin replacement. No subjects were randomized to this arm.

• Experimental

  Aim 2: PCOS + SDB

  One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).

• Experimental

  Aim 2: Matched Controls

  One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP). The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.

• Experimental

  Aim 3: REM frag - SWS supp - Baseline

  Each subject was assessed under three experimental conditions in the following order. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

• Experimental

  Aim 3: REM frag - Baseline - SWS supp

  Each subject was assessed under three experimental conditions in the following order. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

• Experimental

  Aim 3: Baseline - REM frag - SWS supp

  Each subject was assessed under three experimental conditions in the following order. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

• Experimental

  Aim 3: SWS supp - REM frag - Baseline

  Each subject was assessed under three experimental conditions in the following order. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

• Experimental

  Aim 3: Baseline - SWS supp - REM frag

  Each subject was assessed under three experimental conditions in the following order. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

1. Aim 1: Apnea-Hypopnea Index (AHI) [Baseline]

   Time frame · baseline

   Registry description

   Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.

2. Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]

   Time frame · 8 weeks

   Registry description

   Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.

3. Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]

   Time frame · baseline (0 weeks)

   Registry description

   Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.

4. Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]

   Time frame · 8 weeks

   Registry description

   Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.

5. Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]

   Time frame · baseline (0 weeks)

   Registry description

   Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.

6. Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]

   Time frame · 8 weeks

   Registry description

   Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.

7. Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]

   Time frame · Baseline

   Registry description

   Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.

8. Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]

   Time frame · 3 nights

   Registry description

   Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.

No study cites this trial.